NDC 68387-250

Acetaminophen And Codeine

Acetaminophen And Codeine Phosphate

Acetaminophen And Codeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Acetaminophen; Codeine Phosphate.

Product ID68387-250_813e328e-b953-413e-b467-33e71b9211db
NDC68387-250
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen And Codeine
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA089805
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Active Ingredient Strength300 mg/1; mg/1
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-250-15

15 TABLET in 1 BOTTLE, PLASTIC (68387-250-15)
Marketing Start Date2009-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-250-40 [68387025040]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-19
Inactivation Date2019-10-21

NDC 68387-250-60 [68387025060]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-19
Inactivation Date2019-10-21

NDC 68387-250-15 [68387025015]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-19
Inactivation Date2019-10-21

NDC 68387-250-30 [68387025030]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-19
Inactivation Date2019-10-21

NDC 68387-250-90 [68387025090]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-19
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:f94eb4bf-c577-4fa3-bfba-a12a6b821174
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993781
  • NDC Crossover Matching brand name "Acetaminophen And Codeine" or generic name "Acetaminophen And Codeine Phosphate"

    NDCBrand NameGeneric Name
    0440-7026Acetaminophen And Codeineacetaminophen and codeine phosphate
    0440-7027Acetaminophen And Codeineacetaminophen and codeine phosphate
    0603-2337Acetaminophen And Codeineacetaminophen and codeine phosphate
    0603-2338Acetaminophen And Codeineacetaminophen and codeine phosphate
    68071-3059Acetaminophen and CodeineAcetaminophen and Codeine
    68387-250Acetaminophen And CodeineAcetaminophen And Codeine
    68788-9403Acetaminophen and CodeineAcetaminophen and Codeine
    68788-9259Acetaminophen And CodeineAcetaminophen And Codeine
    0603-2339Acetaminophen And CodeineAcetaminophen And Codeine
    71335-0545Acetaminophen and CodeineAcetaminophen and Codeine
    10544-100Acetaminophen and CodeineAcetaminophen and Codeine
    33261-001Acetaminophen And CodeineAcetaminophen And Codeine
    33261-002Acetaminophen And CodeineAcetaminophen And Codeine
    33358-002Acetaminophen And CodeineAcetaminophen And Codeine
    43353-010Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1573Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1574Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1572Acetaminophen and CodeineAcetaminophen and Codeine
    50436-3227Acetaminophen and CodeineAcetaminophen and Codeine
    51655-802ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    51655-808Acetaminophen and CodeineAcetaminophen and Codeine
    52959-003Acetaminophen And CodeineAcetaminophen And Codeine
    52959-446Acetaminophen and CodeineAcetaminophen and Codeine
    53489-160ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    53002-0101Acetaminophen and CodeineAcetaminophen and Codeine
    53489-159ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    53489-161ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-472ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    63187-491Acetaminophen and CodeineAcetaminophen and Codeine
    63187-470Acetaminophen And CodeineAcetaminophen And Codeine
    65162-033Acetaminophen and CodeineAcetaminophen and Codeine
    66267-001Acetaminophen and CodeineAcetaminophen and Codeine
    66267-759Acetaminophen and CodeineAcetaminophen and Codeine
    66336-059Acetaminophen And CodeineAcetaminophen And Codeine
    67046-902Acetaminophen And CodeineAcetaminophen And Codeine
    67046-908Acetaminophen and CodeineAcetaminophen and Codeine
    67296-0544Acetaminophen And CodeineAcetaminophen And Codeine
    67544-882Acetaminophen And CodeineAcetaminophen And Codeine
    67544-474Acetaminophen And CodeineAcetaminophen And Codeine
    61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    0121-0504Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATE
    0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate
    0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate
    0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.