NDC 61919-905

ACETAMINOPHEN AND CODEINE

Acetaminophen And Codeine

ACETAMINOPHEN AND CODEINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct_rx. The primary component is Codeine Phosphate; Acetaminophen.

Product ID61919-905_8ccc18a8-d664-92ab-e053-2a95a90a4d33
NDC61919-905
Product TypeHuman Prescription Drug
Proprietary NameACETAMINOPHEN AND CODEINE
Generic NameAcetaminophen And Codeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-03
Marketing CategoryANDA / ANDA
Application NumberANDA202800
Labeler NameDirect_Rx
Substance NameCODEINE PHOSPHATE; ACETAMINOPHEN
Active Ingredient Strength60 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-905-60

60 TABLET in 1 BOTTLE (61919-905-60)
Marketing Start Date2019-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-905-60 [61919090560]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA202800
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-03

NDC 61919-905-90 [61919090590]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-18
Marketing End Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE60 mg/1

OpenFDA Data

SPL SET ID:8ccc18a8-d663-92ab-e053-2a95a90a4d33
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "ACETAMINOPHEN AND CODEINE" or generic name "Acetaminophen And Codeine"

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
0603-2339Acetaminophen And Codeineacetaminophen and codeine phosphate
10544-100Acetaminophen and Codeineacetaminophen and codeine phosphate
33261-001Acetaminophen And Codeineacetaminophen and codeine phosphate
33261-002Acetaminophen And Codeineacetaminophen and codeine phosphate
33358-002Acetaminophen And Codeineacetaminophen and codeine phosphate
43353-010Acetaminophen and CodeineAcetaminophen and Codeine
50090-1572Acetaminophen and CodeineAcetaminophen and Codeine
50090-1573Acetaminophen and CodeineAcetaminophen and Codeine
50090-1574Acetaminophen and CodeineAcetaminophen and Codeine
50436-3227Acetaminophen and CodeineAcetaminophen and Codeine
51655-802ACETAMINOPHEN AND CODEINECodeine Phosphate and APAP
51655-808Acetaminophen and CodeineAcetaminophen and Codeine
52959-003Acetaminophen And Codeineacetaminophen and codeine phosphate
52959-446Acetaminophen and Codeineacetaminophen and codeine phosphate
53002-0101Acetaminophen and CodeineAcetaminophen and Codeine
53489-159ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
53489-160ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
53489-161ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
61919-472ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
63187-470Acetaminophen 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
71335-0545Acetaminophen and CodeineAcetaminophen and Codeine
63187-491Acetaminophen 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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.