{
"NDC": [
{
"NDCCode": "72789-207-09",
"PackageDescription": "9 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-09) ",
"NDC11Code": "72789-0207-09",
"ProductNDC": "72789-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211111",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "43196-207-09",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (43196-207-09)",
"NDC11Code": "43196-0207-09",
"ProductNDC": "43196-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Instant Hand Sanitizer With Aloe And Vitamin E",
"NonProprietaryName": "Foaming Instant Hand Sanitizer With Aloe And Vitamin E",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "OPI Correctional Industries",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": "7.56",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use. Avoid contact with eyes. If contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, contact a physician or poison control center."
},
{
"NDCCode": "50865-207-09",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (50865-207-09) ",
"NDC11Code": "50865-0207-09",
"ProductNDC": "50865-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Instant Hand Sanitizer With Aloe And Vitamin E",
"NonProprietaryName": "Foaming Instant Hand Sanitizer With Aloe And Vitamin E",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Kutol Products Company, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160531",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use. Avoid contact with eyes. If contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, contact a physician or poison control center."
},
{
"NDCCode": "71919-207-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-207-09) ",
"NDC11Code": "71919-0207-09",
"ProductNDC": "71919-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clematis Erecta",
"NonProprietaryName": "Clematis Recta Flowering Top",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100305",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CLEMATIS RECTA FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100305",
"SamplePackage": "N"
},
{
"NDCCode": "72888-207-09",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72888-207-09) / 10 TABLET in 1 BLISTER PACK (72888-207-08) ",
"NDC11Code": "72888-0207-09",
"ProductNDC": "72888-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72789-207-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-20) ",
"NDC11Code": "72789-0207-20",
"ProductNDC": "72789-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210103",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "72789-207-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-21) ",
"NDC11Code": "72789-0207-21",
"ProductNDC": "72789-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211203",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "72789-207-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-30) ",
"NDC11Code": "72789-0207-30",
"ProductNDC": "72789-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211011",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "72789-207-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-40) ",
"NDC11Code": "72789-0207-40",
"ProductNDC": "72789-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "72789-007-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (72789-007-09) ",
"NDC11Code": "72789-0007-09",
"ProductNDC": "72789-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079067",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis.Metronidazole tablets USP are indicated for the treatment of T. vaginalisinfection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis.Metronidazole tablets USP are indicated in the treatment of asymptomatic T. vaginalisinfection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalisinfection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets USP in cases of reinfection. Amebiasis.Metronidazole tablets USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablet USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections.Metronidazole tablets USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroidesspecies including the B. fragilisgroup ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridiumspecies, Eubacteriumspecies, Peptococcus species,and Peptostreptococcusspecies. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. BACTERIAL SEPTICEMIA caused by Bacteroidesspecies including the B. fragilisgroup and Clostridiumspecies. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroidesspecies including the B. fragilisgroup. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroidesspecies including the B. fragilisgroup. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroidesspecies including the B. fragilisgroup. ENDOCARDITIS caused by Bacteroidesspecies including the B. fragilisgroup. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide and hydrogenated vegetable oil."
},
{
"NDCCode": "72789-148-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (72789-148-09) ",
"NDC11Code": "72789-0148-09",
"ProductNDC": "72789-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150305",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201202",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "72789-167-09",
"PackageDescription": "9 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-09) ",
"NDC11Code": "72789-0167-09",
"ProductNDC": "72789-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207402",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210708",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below:. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "72789-188-09",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-188-09) ",
"NDC11Code": "72789-0188-09",
"ProductNDC": "72789-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078048",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210505",
"SamplePackage": "N"
},
{
"NDCCode": "72789-288-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (72789-288-09) ",
"NDC11Code": "72789-0288-09",
"ProductNDC": "72789-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221118",
"SamplePackage": "N"
},
{
"NDCCode": "72789-393-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (72789-393-09) ",
"NDC11Code": "72789-0393-09",
"ProductNDC": "72789-393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211575",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240425",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditis Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis Nervous System Acute exacerbations of multiple sclerosis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below:. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72789-509-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (72789-509-09) ",
"NDC11Code": "72789-0509-09",
"ProductNDC": "72789-509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone Tablets, Usp, 20 Mg",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212629",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions.",
"Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C 21H 26O 5M.W. 358.44. Each tablet, for oral administration, contains 5, 10, or 20 mg of prednisone. Inactive Ingredients. PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide and talc. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0168-0407-30",
"PackageDescription": "30 g in 1 TUBE (0168-0407-30)",
"NDC11Code": "00168-0407-30",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0168-0407-46",
"PackageDescription": "45 g in 1 TUBE (0168-0407-46)",
"NDC11Code": "00168-0407-46",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0168-0407-99",
"PackageDescription": "100 g in 1 TUBE (0168-0407-99)",
"NDC11Code": "00168-0407-99",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0363-9536-07",
"PackageDescription": "207 mL in 1 BOTTLE, PLASTIC (0363-9536-07) ",
"NDC11Code": "00363-9536-07",
"ProductNDC": "0363-9536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Walgreens",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221102",
"SamplePackage": "N",
"IndicationAndUsage": "Controls flaking , scaling and itching from dandruff."
},
{
"NDCCode": "0591-2159-90",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (0591-2159-90) ",
"NDC11Code": "00591-2159-90",
"ProductNDC": "0591-2159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090490",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "10",
"StrengthUnit": "mg/.96mL",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121212",
"SamplePackage": "N",
"IndicationAndUsage": "Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.",
"Description": "Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo 1% contains 10 mg ciclopirox, USP in a shampoo base consisting of purified water USP, sodium laureth sulfate, disodium laureth sulfosuccinate, sodium chloride USP, and laureth-2. Ciclopirox Shampoo 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is."
},
{
"NDCCode": "10096-1275-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-1275-1) ",
"NDC11Code": "10096-1275-01",
"ProductNDC": "10096-1275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Onduty 24 Hours Sport",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10096-1575-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-1575-1) ",
"NDC11Code": "10096-1575-01",
"ProductNDC": "10096-1575",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Cool Confidence Baby Powder Scent",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10096-1875-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-1875-1) ",
"NDC11Code": "10096-1875-01",
"ProductNDC": "10096-1875",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Onduty 24 Hours Original",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10096-2375-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-2375-1) ",
"NDC11Code": "10096-2375-01",
"ProductNDC": "10096-2375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Cool Confidence Original Scent",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10096-2875-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-2875-1) ",
"NDC11Code": "10096-2875-01",
"ProductNDC": "10096-2875",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Skin So Soft Soft And Sensual",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10096-3175-1",
"PackageDescription": "75 mL in 1 CONTAINER (10096-3175-1) ",
"NDC11Code": "10096-3175-01",
"ProductNDC": "10096-3175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avon Onduty 24 Hours Unscented",
"ProprietaryNameSuffix": "Roll-on Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Avon Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "207",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "10370-207-11",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-207-11) ",
"NDC11Code": "10370-0207-11",
"ProductNDC": "10370-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201374",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).",
"Description": "Lamotrigine Extended-Release Tablets, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to off white crystalline powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets are supplied for oral administration as 100-mg (orange with speckles), 200-mg (blue with speckles), 250-mg (white to off-white with speckles), and 300-mg (gray with speckles) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1 (200 mg tablets only), FD&C Yellow #6 (100 mg tablets only), HPMC 2910, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, propylene glycol, talc, and triethyl citrate. Lamotrigine extended-release tablets contain a clear modified-release membrane coating surrounding the core. The modified-release membrane coating enables a controlled release of drug throughout the gastrointestinal tract, including in the acidic environment of the stomach. The product is designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "11344-965-98",
"PackageDescription": "207 g in 1 TUBE (11344-965-98) ",
"NDC11Code": "11344-0965-98",
"ProductNDC": "11344-965",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Soothing Moisturizing Cream",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Nice-Pak Products, LLC",
"SubstanceName": "OATMEAL",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects and helps relieve minor skin irritation and itching due to: : 1 eczema, 2 rashes."
},
{
"NDCCode": "11410-207-10",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (11410-207-10)",
"NDC11Code": "11410-0207-10",
"ProductNDC": "11410-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071025",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>72789-207-09</NDCCode>
<PackageDescription>9 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-09) </PackageDescription>
<NDC11Code>72789-0207-09</NDC11Code>
<ProductNDC>72789-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
</NDC>
<NDC>
<NDCCode>43196-207-09</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (43196-207-09)</PackageDescription>
<NDC11Code>43196-0207-09</NDC11Code>
<ProductNDC>43196-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Instant Hand Sanitizer With Aloe And Vitamin E</ProprietaryName>
<NonProprietaryName>Foaming Instant Hand Sanitizer With Aloe And Vitamin E</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>OPI Correctional Industries</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.56</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use. Avoid contact with eyes. If contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, contact a physician or poison control center.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50865-207-09</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (50865-207-09) </PackageDescription>
<NDC11Code>50865-0207-09</NDC11Code>
<ProductNDC>50865-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Instant Hand Sanitizer With Aloe And Vitamin E</ProprietaryName>
<NonProprietaryName>Foaming Instant Hand Sanitizer With Aloe And Vitamin E</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Kutol Products Company, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use. Avoid contact with eyes. If contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, contact a physician or poison control center.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-207-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-207-09) </PackageDescription>
<NDC11Code>71919-0207-09</NDC11Code>
<ProductNDC>71919-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clematis Erecta</ProprietaryName>
<NonProprietaryName>Clematis Recta Flowering Top</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100305</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CLEMATIS RECTA FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72888-207-09</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (72888-207-09) / 10 TABLET in 1 BLISTER PACK (72888-207-08) </PackageDescription>
<NDC11Code>72888-0207-09</NDC11Code>
<ProductNDC>72888-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72789-207-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-20) </PackageDescription>
<NDC11Code>72789-0207-20</NDC11Code>
<ProductNDC>72789-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
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<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
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<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
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<PackageDescription>40 CAPSULE in 1 BOTTLE, PLASTIC (72789-207-40) </PackageDescription>
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<LastUpdate>2026-07-09</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
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<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
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<NDC>
<NDCCode>72789-007-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (72789-007-09) </PackageDescription>
<NDC11Code>72789-0007-09</NDC11Code>
<ProductNDC>72789-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079067</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis.Metronidazole tablets USP are indicated for the treatment of T. vaginalisinfection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis.Metronidazole tablets USP are indicated in the treatment of asymptomatic T. vaginalisinfection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalisinfection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets USP in cases of reinfection. Amebiasis.Metronidazole tablets USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablet USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections.Metronidazole tablets USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroidesspecies including the B. fragilisgroup ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridiumspecies, Eubacteriumspecies, Peptococcus species,and Peptostreptococcusspecies. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. BACTERIAL SEPTICEMIA caused by Bacteroidesspecies including the B. fragilisgroup and Clostridiumspecies. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroidesspecies including the B. fragilisgroup. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroidesspecies including the B. fragilisgroup. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroidesspecies including the B. fragilisgroup. ENDOCARDITIS caused by Bacteroidesspecies including the B. fragilisgroup. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
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<NDCCode>72789-148-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (72789-148-09) </PackageDescription>
<NDC11Code>72789-0148-09</NDC11Code>
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<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150305</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201202</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-167-09</NDCCode>
<PackageDescription>9 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-09) </PackageDescription>
<NDC11Code>72789-0167-09</NDC11Code>
<ProductNDC>72789-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207402</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210708</StartMarketingDatePackage>
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<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint SW-0012 White Ink. Composition of imprinting ink [TekPrint SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below:. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
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<ProductNDC>72789-188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078048</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>72789-288-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (72789-288-09) </PackageDescription>
<NDC11Code>72789-0288-09</NDC11Code>
<ProductNDC>72789-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-393-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (72789-393-09) </PackageDescription>
<NDC11Code>72789-0393-09</NDC11Code>
<ProductNDC>72789-393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211575</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditis Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis Nervous System Acute exacerbations of multiple sclerosis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below:. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72789-509-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (72789-509-09) </PackageDescription>
<NDC11Code>72789-0509-09</NDC11Code>
<ProductNDC>72789-509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone Tablets, Usp, 20 Mg</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212629</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C 21H 26O 5M.W. 358.44. Each tablet, for oral administration, contains 5, 10, or 20 mg of prednisone. Inactive Ingredients. PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide and talc. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (0168-0407-30)</PackageDescription>
<NDC11Code>00168-0407-30</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-46</NDCCode>
<PackageDescription>45 g in 1 TUBE (0168-0407-46)</PackageDescription>
<NDC11Code>00168-0407-46</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-99</NDCCode>
<PackageDescription>100 g in 1 TUBE (0168-0407-99)</PackageDescription>
<NDC11Code>00168-0407-99</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0363-9536-07</NDCCode>
<PackageDescription>207 mL in 1 BOTTLE, PLASTIC (0363-9536-07) </PackageDescription>
<NDC11Code>00363-9536-07</NDC11Code>
<ProductNDC>0363-9536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Controls flaking , scaling and itching from dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0591-2159-90</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (0591-2159-90) </PackageDescription>
<NDC11Code>00591-2159-90</NDC11Code>
<ProductNDC>0591-2159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090490</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/.96mL</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.</IndicationAndUsage>
<Description>Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo 1% contains 10 mg ciclopirox, USP in a shampoo base consisting of purified water USP, sodium laureth sulfate, disodium laureth sulfosuccinate, sodium chloride USP, and laureth-2. Ciclopirox Shampoo 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>10096-1275-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-1275-1) </PackageDescription>
<NDC11Code>10096-1275-01</NDC11Code>
<ProductNDC>10096-1275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Onduty 24 Hours Sport</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-1575-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-1575-1) </PackageDescription>
<NDC11Code>10096-1575-01</NDC11Code>
<ProductNDC>10096-1575</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Cool Confidence Baby Powder Scent</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-1875-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-1875-1) </PackageDescription>
<NDC11Code>10096-1875-01</NDC11Code>
<ProductNDC>10096-1875</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Onduty 24 Hours Original</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-2375-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-2375-1) </PackageDescription>
<NDC11Code>10096-2375-01</NDC11Code>
<ProductNDC>10096-2375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Cool Confidence Original Scent</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-2875-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-2875-1) </PackageDescription>
<NDC11Code>10096-2875-01</NDC11Code>
<ProductNDC>10096-2875</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Skin So Soft Soft And Sensual</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-3175-1</NDCCode>
<PackageDescription>75 mL in 1 CONTAINER (10096-3175-1) </PackageDescription>
<NDC11Code>10096-3175-01</NDC11Code>
<ProductNDC>10096-3175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avon Onduty 24 Hours Unscented</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Anti-perspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Avon Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>207</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10370-207-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-207-11) </PackageDescription>
<NDC11Code>10370-0207-11</NDC11Code>
<ProductNDC>10370-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201374</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).</IndicationAndUsage>
<Description>Lamotrigine Extended-Release Tablets, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to off white crystalline powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets are supplied for oral administration as 100-mg (orange with speckles), 200-mg (blue with speckles), 250-mg (white to off-white with speckles), and 300-mg (gray with speckles) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1 (200 mg tablets only), FD&C Yellow #6 (100 mg tablets only), HPMC 2910, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, propylene glycol, talc, and triethyl citrate. Lamotrigine extended-release tablets contain a clear modified-release membrane coating surrounding the core. The modified-release membrane coating enables a controlled release of drug throughout the gastrointestinal tract, including in the acidic environment of the stomach. The product is designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>11344-965-98</NDCCode>
<PackageDescription>207 g in 1 TUBE (11344-965-98) </PackageDescription>
<NDC11Code>11344-0965-98</NDC11Code>
<ProductNDC>11344-965</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema Soothing Moisturizing Cream</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Nice-Pak Products, LLC</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects and helps relieve minor skin irritation and itching due to: : 1 eczema, 2 rashes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11410-207-10</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (11410-207-10)</PackageDescription>
<NDC11Code>11410-0207-10</NDC11Code>
<ProductNDC>11410-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Repairing</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071025</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>