NDC 52959-003

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 H.j. Harkins Company, Inc.. The primary component is Codeine Phosphate; Acetaminophen.

Product ID52959-003_75c9fa2e-a170-69f7-e053-2a91aa0ad11a
NDC52959-003
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen And Codeine
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1988-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA089805
Labeler NameH.J. Harkins Company, Inc.
Substance NameCODEINE PHOSPHATE; ACETAMINOPHEN
Active Ingredient Strength30 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-003-02

120 TABLET in 1 BOTTLE, PLASTIC (52959-003-02)
Marketing Start Date1988-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-003-50 [52959000350]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-15 [52959000315]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-60 [52959000360]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-45 [52959000345]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-42 [52959000342]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-10 [52959000310]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-04 [52959000304]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-30 [52959000330]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-02 [52959000302]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-28 [52959000328]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-75 [52959000375]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-00 [52959000300]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-20 [52959000320]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-84 [52959000384]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-25 [52959000325]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-24 [52959000324]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-14 [52959000314]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-12 [52959000312]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-90 [52959000390]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-06 [52959000306]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-16 [52959000316]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-40 [52959000340]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE30 mg/1

OpenFDA Data

SPL SET ID:97b0ee29-d08e-4d9b-82ed-3ce287dbec28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993890
  • 993781
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]