FDA.reportPublic FDA data

Application 088627

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoNo

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 UTC2019-12A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-0674a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A088627-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA1985-03-06ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A088627-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088627-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A088627-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088627-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088627-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088627-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A088627-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088627-001AA1ea99ee380514…

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 2 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAurolife Pharma, LLC02386806-02d4-47e3-9c8b-7810146ee7952025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEElite Laboratories, Inc.6286e128-1288-4dc0-b14b-f04a0e2a22f92025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack68f4227b-5010-4996-8f8f-024aa546dee62025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack3e41e55f-7e41-4653-aadb-32a9e47962d92025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAsclemed USA, Inc.682ef287-647a-4d89-9bbf-75907ebd10f22025-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacka6e9b316-549d-4058-8c08-407e4ce5c2552025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC36988ba2-cefd-99f8-e063-6294a90aa41a2025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC3698e0ff-6a1c-e1ad-e063-6294a90a163a2025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.7ab27392-9c6e-4ec3-85e7-06b43fcab3b12025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.caa96b80-d8a7-4920-9d5c-717435e798de2025-06-02Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.31d24067-3c25-0f1a-e063-6394a90a9f1d2025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.2e88442f-a6a9-a899-e063-6294a90ac08d2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.73e2086e-f513-537f-e053-2991aa0a13482025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEDirect_Rxe78e50c0-36da-528e-e053-2995a90a3d802025-01-22Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e932a34-a7d3-e4ec-e063-6294a90a25b12025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAphena Pharma Solutions - Tennessee, LLCd53bf9b7-1652-4287-a0c1-e89f6f0cb7f12025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP5d9123f6-b322-4fa0-bf48-6335a6adcbb82025-01-01Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEQuality Care Products, LLC3b455938-7bbc-4626-939b-40b37709befb2024-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack3f7737d1-ec78-467e-8903-9cb8eba0ab0b2024-08-22Boxed 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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
61502-903ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEEPM Packaging IncANDACurrent
63629-2945Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-2945Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent