Application 088629
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | No | Yes |
| 002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;15MG | No | No |
| 003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | |
| A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | ||
| A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088629-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | 1985-03-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088629-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | 1985-03-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088629-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | RLD | 1985-03-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088629-003 | AA | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 40d4a71e-341e-48b3-b925-ba35b7910dff | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | PAI Holdings, LLC dba PAI Pharma | 95ac6875-6b14-4cde-8efb-80704e39b8d8 | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 4c966d73-77c6-4514-954e-57aa06a080c6 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 1fe39679-fd58-4d2c-ba61-49d492a2b087 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Unit Dose Solutions, Inc. | 537245e8-5e2a-c3e0-e063-6394a90ac858 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | St. Mary's Medical Park Pharmacy | eac5f350-93e5-4dc2-e053-2a95a90aed60 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Redpharm Drug | 52617668-acc3-65cd-e063-6294a90ab919 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | ff77a959-c77a-4911-8f7c-e2a3e24a6305 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | f308fd07-f004-42de-963d-426b268bba93 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 6980bfc5-15e4-48ec-9346-6f09f8f78900 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | e73b17c4-9f24-4b32-8920-61c58c40a714 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 879db1b5-6365-4151-9879-80d8a2a3cd8a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Genus Lifesciences Inc. | 95a5d638-3072-4c37-a4cd-f8550328e2c6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | dff53120-a609-4720-bd69-2391798c7dee | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | ST. MARY'S MEDICAL PARK PHARMACY | 48eb36ee-e9dc-a719-e063-6394a90aa85e | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 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 | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42254-145 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Rebel Distributors Corp | ANDA | Current |
| 61919-273 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | DirectRX | ANDA | Current |
| 68788-9736 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9736 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1592 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1592 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1592 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | REMEDYREPACK INC. | ANDA | Current |
| 71335-0701 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0701 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0701 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76106 | ORIG | 2023-11-02 |