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 1 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.4c966d73-77c6-4514-954e-57aa06a080c62026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.1fe39679-fd58-4d2c-ba61-49d492a2b0872026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESpecGx LLCeadc80fa-13c3-471a-a22f-6fe7e1ab290f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESt. Mary's Medical Park Pharmacyeac5f350-93e5-4dc2-e053-2a95a90aed602026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedpharm Drug52617668-acc3-65cd-e063-6294a90ab9192026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackff77a959-c77a-4911-8f7c-e2a3e24a63052026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackf308fd07-f004-42de-963d-426b268bba932026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacke73b17c4-9f24-4b32-8920-61c58c40a7142026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack879db1b5-6365-4151-9879-80d8a2a3cd8a2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEGenus Lifesciences Inc.95a5d638-3072-4c37-a4cd-f8550328e2c62026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions9ca1321e-380a-48d7-8a58-c6501858c1c02026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutionsdff53120-a609-4720-bd69-2391798c7dee2026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions297dc9ff-e34f-434b-b1a4-4c995a5bac8b2026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEST. MARY'S MEDICAL PARK PHARMACY48eb36ee-e9dc-a719-e063-6394a90aa85e2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed 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