{
"NDC": [
{
"NDCCode": "70752-161-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-161-14) ",
"NDC11Code": "70752-0161-14",
"ProductNDC": "70752-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-161-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (70752-161-10) ",
"NDC11Code": "70752-0161-10",
"ProductNDC": "70752-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-161-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-161-11) ",
"NDC11Code": "70752-0161-11",
"ProductNDC": "70752-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-131-14",
"PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (70752-131-14) ",
"NDC11Code": "70752-0131-14",
"ProductNDC": "70752-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213567",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N",
"Description": "Methylphenidate HCl Oral Solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate HCl Oral Solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, natural & artificial grape flavor, Polyethylene Glycol 1450 and purified water."
},
{
"NDCCode": "70752-132-14",
"PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (70752-132-14) ",
"NDC11Code": "70752-0132-14",
"ProductNDC": "70752-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213567",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N",
"Description": "Methylphenidate HCl Oral Solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate HCl Oral Solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, natural & artificial grape flavor, Polyethylene Glycol 1450 and purified water."
},
{
"NDCCode": "70752-136-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70752-136-14) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "70752-0136-14",
"ProductNDC": "70752-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213761",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210602",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (l mg/mL) include: citric acid anhydrous, FD&C Red #40, glycerin, poloxamer 188, purified water, natural/artificial raspberry flavor, sodium benzoate, sorbitol and contains alcohol 0.05% v/v. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP, 100 mg per 5 mL (20 mg/mL) include: citric acid anhydrous, D&C Yellow #10, natural berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol."
},
{
"NDCCode": "70752-141-14",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (70752-141-14) ",
"NDC11Code": "70752-0141-14",
"ProductNDC": "70752-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216376",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220806",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen, and Caffeine Capsules USP are supplied in capsule form for oral administration. Each capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients:. colloidal silicon dioxide, croscarmellose sodium, Stearic acid, talc and microcrystalline cellulose with capsule shell composed of gelatin, titanium dioxide and edible imprinting ink-Tek PrintTM SB-1081 Red Ink (Shellac, Propylene Glycol, Sodium Hydroxide, Titanium Dioxide, Povidone and FD&C Red #40 Aluminum Lake-E129). Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula."
},
{
"NDCCode": "70752-142-14",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (70752-142-14) ",
"NDC11Code": "70752-0142-14",
"ProductNDC": "70752-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214287",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP ...................................................................................... 50 mg acetaminophen, USP ........................................................................... 325 mg caffeine, USP ........................................................................................ 40 mg. Inactive Ingredients: colloidal silicon dioxide, crospovidone, gelatinized starch, FD&C blue #1, microcrystalline cellulose, povidone and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 M.W.= 224.26. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H10N4O2 M.W. = 151.16. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
},
{
"NDCCode": "70752-144-14",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (70752-144-14) ",
"NDC11Code": "70752-0144-14",
"ProductNDC": "70752-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214288",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 300; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mg. WARNING: May be habit-forming. acetaminophen USP…………….300 mg caffeine USP……………………..40 mg. Inactive Ingredients: D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, microcrystalline cellulose, stearic acid, talc and titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula."
},
{
"NDCCode": "70752-147-14",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14) ",
"NDC11Code": "70752-0147-14",
"ProductNDC": "70752-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214305",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "50; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg. In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Crospovidone, Croscarmellose Sodium, Povidone, Microcrystalline Cellulose, Pregelatinized Starch, D&C Yellow #10 Lake, FD&C Red #40 Lake and Stearic Acid. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. MOLECULAR WEIGHT = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MOLECULAR WEIGHT = 151.16."
},
{
"NDCCode": "70752-148-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-148-14) ",
"NDC11Code": "70752-0148-14",
"ProductNDC": "70752-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214291",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "50; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital and acetaminophen are supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each tablet contains. Butalbital …………………………………………….50 mg. Warning: May be habit-forming. Acetaminophen ……………………………………...325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "70752-162-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-162-14) ",
"NDC11Code": "70752-0162-14",
"ProductNDC": "70752-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "32.4",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-163-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-163-14) ",
"NDC11Code": "70752-0163-14",
"ProductNDC": "70752-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "64.8",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-164-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-164-14) ",
"NDC11Code": "70752-0164-14",
"ProductNDC": "70752-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "97.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-165-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-165-14) ",
"NDC11Code": "70752-0165-14",
"ProductNDC": "70752-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-166-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-166-14) ",
"NDC11Code": "70752-0166-14",
"ProductNDC": "70752-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-167-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-167-14) ",
"NDC11Code": "70752-0167-14",
"ProductNDC": "70752-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-168-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-168-14) ",
"NDC11Code": "70752-0168-14",
"ProductNDC": "70752-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "20276-161-14",
"PackageDescription": "414 mL in 1 BOTTLE, PUMP (20276-161-14)",
"NDC11Code": "20276-0161-14",
"ProductNDC": "20276-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lucky Antibacterial Hand Soap",
"ProprietaryNameSuffix": "Supersoft",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Delta Brands Inc",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "24909-161-14",
"PackageDescription": "1 TUBE in 1 CARTON (24909-161-14) > 14 g in 1 TUBE",
"NDC11Code": "24909-0161-14",
"ProductNDC": "24909-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Fast And Natural Wart Removal",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140310",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2024-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140310",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of warts."
},
{
"NDCCode": "24909-161-15",
"PackageDescription": "14 g in 1 TUBE (24909-161-15) ",
"NDC11Code": "24909-0161-15",
"ProductNDC": "24909-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Fast And Natural Wart Removal",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140310",
"EndMarketingDate": "20270709",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221122",
"EndMarketingDatePackage": "20270709",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of warts."
},
{
"NDCCode": "43598-161-33",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-161-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "43598-0161-33",
"ProductNDC": "43598-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202194",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "43598-161-52",
"PackageDescription": "1 BOTTLE in 1 CARTON (43598-161-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "43598-0161-52",
"ProductNDC": "43598-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202194",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "47046-161-02",
"PackageDescription": "1 TUBE in 1 CARTON (47046-161-02) > 14.2 g in 1 TUBE (47046-161-01) ",
"NDC11Code": "47046-0161-02",
"ProductNDC": "47046-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180712",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Anicare Pharmaceuticals Pvt. Ltd",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180712",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "50066-161-51",
"PackageDescription": "1 TUBE in 1 CARTON (50066-161-51) > 14 g in 1 TUBE",
"NDC11Code": "50066-0161-51",
"ProductNDC": "50066-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Bells Pomade",
"NonProprietaryName": "Triple Antibiotic Plus Pain Relief",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120516",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Genomma lab USA Inc.",
"SubstanceName": "BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 10000; 3.5; 10",
"StrengthUnit": "[USP'U]/g; [USP'U]/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "First aid helps prevent infection in and temporarily relieves pain due to: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "62257-161-14",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (62257-161-14) ",
"NDC11Code": "62257-0161-14",
"ProductNDC": "62257-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lynx Foamy Pcmx Antiseptic Hand And Body Wash 6876",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170207",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ABC Compounding Co., Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170207",
"SamplePackage": "N",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin."
},
{
"NDCCode": "62673-161-14",
"PackageDescription": "1 TUBE in 1 CARTON (62673-161-14) / 113 g in 1 TUBE",
"NDC11Code": "62673-0161-14",
"ProductNDC": "62673-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diabetic Advanced Healing Cream",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Neoteric Cosmetics, Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": ".01",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the dry effects of wind and cold weather."
},
{
"NDCCode": "64205-161-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (64205-161-14)",
"NDC11Code": "64205-0161-14",
"ProductNDC": "64205-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Misoprostol",
"NonProprietaryName": "Misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091667",
"LabelerName": "ReadyMeds",
"SubstanceName": "MISOPROSTOL",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.",
"Description": "Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, microcrystalline cellulose, and crospovidone."
},
{
"NDCCode": "68546-490-42",
"PackageDescription": "2 KIT in 1 BLISTER PACK (68546-490-42) / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) ",
"NDC11Code": "68546-0490-42",
"ProductNDC": "68546-490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Austedo Xr",
"NonProprietaryName": "Deutetrabenazine",
"DosageFormName": "KIT",
"StartMarketingDate": "20230221",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216354",
"LabelerName": "Teva Neuroscience, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230221",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "Y",
"IndicationAndUsage": "AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].",
"Description": "AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake."
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"Description": "AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210602</StartMarketingDate>
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<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (l mg/mL) include: citric acid anhydrous, FD&C Red #40, glycerin, poloxamer 188, purified water, natural/artificial raspberry flavor, sodium benzoate, sorbitol and contains alcohol 0.05% v/v. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP, 100 mg per 5 mL (20 mg/mL) include: citric acid anhydrous, D&C Yellow #10, natural berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol.</Description>
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<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (70752-141-14) </PackageDescription>
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<ProductNDC>70752-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20220806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216376</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, and Caffeine Capsules USP are supplied in capsule form for oral administration. Each capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients:. colloidal silicon dioxide, croscarmellose sodium, Stearic acid, talc and microcrystalline cellulose with capsule shell composed of gelatin, titanium dioxide and edible imprinting ink-Tek PrintTM SB-1081 Red Ink (Shellac, Propylene Glycol, Sodium Hydroxide, Titanium Dioxide, Povidone and FD&C Red #40 Aluminum Lake-E129). Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula.</Description>
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<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (70752-142-14) </PackageDescription>
<NDC11Code>70752-0142-14</NDC11Code>
<ProductNDC>70752-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214287</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
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<DEASchedule>CIII</DEASchedule>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP ...................................................................................... 50 mg acetaminophen, USP ........................................................................... 325 mg caffeine, USP ........................................................................................ 40 mg. Inactive Ingredients: colloidal silicon dioxide, crospovidone, gelatinized starch, FD&C blue #1, microcrystalline cellulose, povidone and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 M.W.= 224.26. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H10N4O2 M.W. = 151.16. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70752-144-14</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (70752-144-14) </PackageDescription>
<NDC11Code>70752-0144-14</NDC11Code>
<ProductNDC>70752-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214288</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mg. WARNING: May be habit-forming. acetaminophen USP…………….300 mg caffeine USP……………………..40 mg. Inactive Ingredients: D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, microcrystalline cellulose, stearic acid, talc and titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70752-147-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (70752-147-14) </PackageDescription>
<NDC11Code>70752-0147-14</NDC11Code>
<ProductNDC>70752-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital And Acetaminophen</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214305</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>50; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg. In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Crospovidone, Croscarmellose Sodium, Povidone, Microcrystalline Cellulose, Pregelatinized Starch, D&C Yellow #10 Lake, FD&C Red #40 Lake and Stearic Acid. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. MOLECULAR WEIGHT = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MOLECULAR WEIGHT = 151.16.</Description>
</NDC>
<NDC>
<NDCCode>70752-148-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-148-14) </PackageDescription>
<NDC11Code>70752-0148-14</NDC11Code>
<ProductNDC>70752-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital And Acetaminophen</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214291</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>50; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital and acetaminophen are supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each tablet contains. Butalbital …………………………………………….50 mg. Warning: May be habit-forming. Acetaminophen ……………………………………...325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>70752-162-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-162-14) </PackageDescription>
<NDC11Code>70752-0162-14</NDC11Code>
<ProductNDC>70752-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>32.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-163-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-163-14) </PackageDescription>
<NDC11Code>70752-0163-14</NDC11Code>
<ProductNDC>70752-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>64.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-164-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-164-14) </PackageDescription>
<NDC11Code>70752-0164-14</NDC11Code>
<ProductNDC>70752-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>97.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-165-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-165-14) </PackageDescription>
<NDC11Code>70752-0165-14</NDC11Code>
<ProductNDC>70752-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-166-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-166-14) </PackageDescription>
<NDC11Code>70752-0166-14</NDC11Code>
<ProductNDC>70752-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-167-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-167-14) </PackageDescription>
<NDC11Code>70752-0167-14</NDC11Code>
<ProductNDC>70752-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-168-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70752-168-14) </PackageDescription>
<NDC11Code>70752-0168-14</NDC11Code>
<ProductNDC>70752-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>20276-161-14</NDCCode>
<PackageDescription>414 mL in 1 BOTTLE, PUMP (20276-161-14)</PackageDescription>
<NDC11Code>20276-0161-14</NDC11Code>
<ProductNDC>20276-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lucky Antibacterial Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Supersoft</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Delta Brands Inc</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24909-161-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (24909-161-14) > 14 g in 1 TUBE</PackageDescription>
<NDC11Code>24909-0161-14</NDC11Code>
<ProductNDC>24909-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Fast And Natural Wart Removal</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-161-15</NDCCode>
<PackageDescription>14 g in 1 TUBE (24909-161-15) </PackageDescription>
<NDC11Code>24909-0161-15</NDC11Code>
<ProductNDC>24909-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Fast And Natural Wart Removal</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140310</StartMarketingDate>
<EndMarketingDate>20270709</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<EndMarketingDatePackage>20270709</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-161-33</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-161-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0161-33</NDC11Code>
<ProductNDC>43598-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202194</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-161-52</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43598-161-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0161-52</NDC11Code>
<ProductNDC>43598-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202194</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47046-161-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (47046-161-02) > 14.2 g in 1 TUBE (47046-161-01) </PackageDescription>
<NDC11Code>47046-0161-02</NDC11Code>
<ProductNDC>47046-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Anicare Pharmaceuticals Pvt. Ltd</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50066-161-51</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50066-161-51) > 14 g in 1 TUBE</PackageDescription>
<NDC11Code>50066-0161-51</NDC11Code>
<ProductNDC>50066-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Bells Pomade</ProprietaryName>
<NonProprietaryName>Triple Antibiotic Plus Pain Relief</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Genomma lab USA Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 10000; 3.5; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; [USP'U]/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>First aid helps prevent infection in and temporarily relieves pain due to: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62257-161-14</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (62257-161-14) </PackageDescription>
<NDC11Code>62257-0161-14</NDC11Code>
<ProductNDC>62257-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lynx Foamy Pcmx Antiseptic Hand And Body Wash 6876</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62673-161-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62673-161-14) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>62673-0161-14</NDC11Code>
<ProductNDC>62673-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diabetic Advanced Healing Cream</ProprietaryName>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250430</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Neoteric Cosmetics, Inc.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the dry effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64205-161-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (64205-161-14)</PackageDescription>
<NDC11Code>64205-0161-14</NDC11Code>
<ProductNDC>64205-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Misoprostol</ProprietaryName>
<NonProprietaryName>Misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091667</ApplicationNumber>
<LabelerName>ReadyMeds</LabelerName>
<SubstanceName>MISOPROSTOL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.</IndicationAndUsage>
<Description>Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, microcrystalline cellulose, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>68546-490-42</NDCCode>
<PackageDescription>2 KIT in 1 BLISTER PACK (68546-490-42) / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) </PackageDescription>
<NDC11Code>68546-0490-42</NDC11Code>
<ProductNDC>68546-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Austedo Xr</ProprietaryName>
<NonProprietaryName>Deutetrabenazine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230221</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216354</ApplicationNumber>
<LabelerName>Teva Neuroscience, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.</Description>
</NDC>
<NDC>
<NDCCode>68546-490-52</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (68546-490-52) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) </PackageDescription>
<NDC11Code>68546-0490-52</NDC11Code>
<ProductNDC>68546-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Austedo Xr</ProprietaryName>
<NonProprietaryName>Deutetrabenazine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230221</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216354</ApplicationNumber>
<LabelerName>Teva Neuroscience, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.</Description>
</NDC>
</NDCList>