FDA.reportPublic FDA data

Application 088628

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-0674a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A088628-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088628-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A088628-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088628-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088628-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088628-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A088628-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088628-001AA1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack18315a6f-9e89-46d7-81d3-905b8a51aa792024-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack30da1bea-2dbc-4086-a5cf-8ed471bb65932024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack9f2127d9-d60b-42d3-9b6c-798e63dd68d12024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e01f923-38c1-9b59-e063-6394a90a22f12024-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LPa8f8bb34-6d61-47a8-b58b-0b67634580522024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEClinical Solutions Wholesale, LLC5603ed2f-0b6c-46fd-8c76-c4e4d188a3432024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackebdbc975-4e0e-4b83-8cf4-f29da829113a2024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEClinical Solutions Wholesale, LLC331d92ac-7287-47c7-b573-b5e6cd58c9812024-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7792Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42254-022Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRebel Distributors CorpANDACurrent
51079-161Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateMylan Institutional Inc.ANDACurrent
51079-161Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateMylan Institutional Inc.ANDACurrent
61919-328ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-328ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-328ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-328ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect RXANDACurrent
63629-1494Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
67046-903Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateContract Pharmacy Services-PAANDACurrent
67296-0041Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRedPharm Drug Inc.ANDACurrent
68788-0285Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0285Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
71205-001Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
71205-001Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent