Application 040419
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;15MG | No | Yes |
| 002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | No | No |
| 003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 |
| A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 |
| A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040419-001 | AA |
| A040419-002 | AA |
| A040419-003 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040419-001 | AA | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040419-002 | AA | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040419-003 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040419-003 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-001 | AA | 1 | 79d66fd596c7… |
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 | Clinical Solutions Wholesale, LLC | 331d92ac-7287-47c7-b573-b5e6cd58c981 | 2024-01-08 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
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 |
|---|---|---|---|---|---|
| 68071-4430 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4430 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4475 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4475 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4475 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4475 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4533 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4533 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4533 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7835 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7835 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7859 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7859 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9506 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-3575 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1522 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1522 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71610-111 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-376 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate | Direct_Rx | ANDA | Current |