Application 086366
- Type
- ANDA
- Sponsor
- ACI HEALTHCARE LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | SOLUTION;ORAL | 120MG/5ML;12MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 |
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 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A086366-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | Approved before 1982 | f41ea6bd6efb… |
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 | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Aurolife Pharma, LLC | 02386806-02d4-47e3-9c8b-7810146ee795 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Elite Laboratories, Inc. | 6286e128-1288-4dc0-b14b-f04a0e2a22f9 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 68f4227b-5010-4996-8f8f-024aa546dee6 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3e41e55f-7e41-4653-aadb-32a9e47962d9 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Asclemed USA, Inc. | 682ef287-647a-4d89-9bbf-75907ebd10f2 | 2025-08-17 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | a6e9b316-549d-4058-8c08-407e4ce5c255 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Advanced Rx of Tennessee, LLC | 36988ba2-cefd-99f8-e063-6294a90aa41a | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Advanced Rx of Tennessee, LLC | 3698e0ff-6a1c-e1ad-e063-6294a90a163a | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 7ab27392-9c6e-4ec3-85e7-06b43fcab3b1 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | caa96b80-d8a7-4920-9d5c-717435e798de | 2025-06-02 | Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 31d24067-3c25-0f1a-e063-6394a90a9f1d | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 2e88442f-a6a9-a899-e063-6294a90ac08d | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 73e2086e-f513-537f-e053-2991aa0a1348 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Direct_Rx | e78e50c0-36da-528e-e053-2995a90a3d80 | 2025-01-22 | Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 1e932a34-a7d3-e4ec-e063-6294a90a25b1 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Aphena Pharma Solutions - Tennessee, LLC | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 5d9123f6-b322-4fa0-bf48-6335a6adcbb8 | 2025-01-01 | Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Quality Care Products, LLC | 3b455938-7bbc-4626-939b-40b37709befb | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 2024-08-22 | 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.