Acetaminophen and Codeine Phosphate
- Product NDC
- 60760-466
- 11-digit product format
- 607600466
- Labeler code
- 60760
- Product ID
- 60760-466_7b324564-ca9e-7c37-e053-2a91aa0a2616
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA202800
- Marketing category
- ANDA
- Marketing start
- 2018-05-08
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 60760-466 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 60760-466 | 60760-466-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | |
| A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | |
| A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202800-001 | AA |
| A202800-002 | AA |
| A202800-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2013-04-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2013-04-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202800-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2013-04-15 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202800-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202800-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202800-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202800-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202800-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202800-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202800-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202800-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202800-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202800-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202800-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202800-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202800-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202800-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202800-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202800-001 | AA | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Aurolife Pharma, LLC | 02386806-02d4-47e3-9c8b-7810146ee795 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 30da1bea-2dbc-4086-a5cf-8ed471bb6593 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 9f2127d9-d60b-42d3-9b6c-798e63dd68d1 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 8f12016d-904f-00b4-e053-2a95a90ad02a | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 80c9a58d-98ae-5497-e053-2991aa0a61fb | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 7d69403e-90d0-7a80-e053-2a91aa0a5552 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 75b50751-5237-4e3e-b7ee-1605c0602f3b | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 202800 ANDA202800 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-466-30 | EA - Each | 60760-466 | 16ff529b-e109-4428-9848-a1aba23eb56e | 1 | 2018-06-11 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-466-30 | 60760046630 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-466-30) | 30 tablet | 2018-05-08 | 0000-00-00 | No | No | Current |