ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 0406-0484
- 11-digit product format
- 004060484
- Labeler code
- 0406
- Product ID
- 0406-0484_d718c5ef-69f7-4342-8ac6-772b45f6a726
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2001-05-31
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 30 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0406-0484 | 0406-0484-20 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0406-0484 | 0406-0484-50 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0406-0484 | 0406-0484-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0406-0484 | 0406-0484-20 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 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 | 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040419-001 | AA | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| GSL05Y1MN6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| eadc80fa-13c3-471a-a22f-6fe7e1ab290f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-0484-01 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 100 in 1 BOTTLE | TABLET | 100 | 50 | |
| 0406-0484-03 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BOTTLE | TABLET | 30 | 50 | |
| 0406-0484-10 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 1000 in 1 BOTTLE | TABLET | 1000 | 50 | |
| 0406-0484-20 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | 50 | |
| 0406-0484-23 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 1 in 1 BLISTER PACK | TABLET | 1 | 50 | |
| 0406-0484-50 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 50 in 1 BOTTLE | TABLET | 50 | 50 | |
| 0406-0484-62 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 100 in 1 BLISTER PACK | TABLET | 100 | 50 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-0484-01 | EA - Each | 0406-0484 | b1dcf439-81e5-4443-af87-4b08927b024e | 1 | 2012-07-24 |
| 0406-0484-03 | EA - Each | 0406-0484 | e2aad44f-448d-49d6-8f37-2745d164f215 | 1 | 2012-07-24 |
| 0406-0484-10 | EA - Each | 0406-0484 | a8f8f0c6-63dc-49e6-9113-99d3c70e328c | 1 | 2012-07-24 |
| 0406-0484-20 | EA - Each | 0406-0484 | 2668159f-ffe7-4d03-83cf-ce04593fa93d | 1 | 2012-07-24 |
| 0406-0484-23 | EA - Each | 0406-0484 | a051cc57-61bf-4949-a3e9-ea59aacb58eb | 1 | 2013-03-03 |
| 0406-0484-50 | EA - Each | 0406-0484 | 139f62c7-6bad-4326-97d2-e41afad07574 | 1 | 2012-07-24 |
| 0406-0484-62 | EA - Each | 0406-0484 | 8ee82fc6-9fac-495e-a9d7-0c35a4858691 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 0406-0484 |
| 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 | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | a6e9b316-549d-4058-8c08-407e4ce5c255 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE | ACETAMINOPHEN AND CODEINE | Direct_Rx | 8d7ca633-4448-3507-e053-2a95a90a1287 | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE | ACETAMINOPHEN AND CODEINE | Direct_Rx | 8d7d6fa4-cc9f-6b4b-e053-2995a90a7286 | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 73e2086e-f513-537f-e053-2991aa0a1348 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Direct_Rx | e78e50c0-36da-528e-e053-2995a90a3d80 | 2025-01-22 | Warnings, Adverse reactions | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| 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 | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 6f2ce909-6356-1c2c-e053-2a91aa0a0135 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 3b455938-7bbc-4626-939b-40b37709befb | 3394 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 3b455938-7bbc-4626-939b-40b37709befb | 3394 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 3b455938-7bbc-4626-939b-40b37709befb | 3394 |
| 993770 | codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet | PSN | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993770 | acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet | SCD | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993770 | APAP 300 MG / codeine phosphate 15 MG Oral Tablet | SY | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 50 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | dff53120-a609-4720-bd69-2391798c7dee | 12 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 12 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 12 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | dff53120-a609-4720-bd69-2391798c7dee | 12 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 12 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | dff53120-a609-4720-bd69-2391798c7dee | 12 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 9 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 9 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 9 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 9 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 9 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 9 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 57e81711-44b8-2eee-e053-2991aa0aee26 | 7 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 8d7d6fa4-cc9f-6b4b-e053-2995a90a7286 | 7 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 7 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 7 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 57e81711-44b8-2eee-e053-2991aa0aee26 | 7 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 8d7d6fa4-cc9f-6b4b-e053-2995a90a7286 | 7 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 7 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 57e81711-44b8-2eee-e053-2991aa0aee26 | 7 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 8d7d6fa4-cc9f-6b4b-e053-2995a90a7286 | 7 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 2453d635-989d-4569-96b3-4efaf61cca71 | 6 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 2453d635-989d-4569-96b3-4efaf61cca71 | 6 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 2453d635-989d-4569-96b3-4efaf61cca71 | 6 |
| 993770 | codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet | PSN | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 73e2086e-f513-537f-e053-2991aa0a1348 | 5 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 6f2ce909-6356-1c2c-e053-2a91aa0a0135 | 5 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 331d92ac-7287-47c7-b573-b5e6cd58c981 | 5 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993770 | acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet | SCD | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 6f2ce909-6356-1c2c-e053-2a91aa0a0135 | 5 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 331d92ac-7287-47c7-b573-b5e6cd58c981 | 5 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 73e2086e-f513-537f-e053-2991aa0a1348 | 5 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993770 | APAP 300 MG / codeine phosphate 15 MG Oral Tablet | SY | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 73e2086e-f513-537f-e053-2991aa0a1348 | 5 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 331d92ac-7287-47c7-b573-b5e6cd58c981 | 5 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 6f2ce909-6356-1c2c-e053-2a91aa0a0135 | 5 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 5 |
| 993770 | codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet | PSN | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993770 | acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet | SCD | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993770 | APAP 300 MG / codeine phosphate 15 MG Oral Tablet | SY | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 0332c7ca-7522-4fb5-96ea-2abe47322119 | 4 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 8d7ca633-4448-3507-e053-2a95a90a1287 | 2 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | d694dedf-337d-4d6f-e053-2a95a90a819b | 2 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 35185014-ab86-4df9-b274-88a38d01697b | 2 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 8d7ca633-4448-3507-e053-2a95a90a1287 | 2 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 35185014-ab86-4df9-b274-88a38d01697b | 2 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | d694dedf-337d-4d6f-e053-2a95a90a819b | 2 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | d694dedf-337d-4d6f-e053-2a95a90a819b | 2 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 35185014-ab86-4df9-b274-88a38d01697b | 2 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 8d7ca633-4448-3507-e053-2a95a90a1287 | 2 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 17b567bb-05c1-4309-b8ea-59009f08abd5 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 3c153389-4361-4a39-b7da-151ffc566f24 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 8d7ca347-ad91-0ae1-e053-2995a90ac400 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | eac5f350-93e5-4dc2-e053-2a95a90aed60 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | b2d0594b-c8df-4d29-8292-a1626bf09c1f | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 403f109d-618d-404d-9ce6-11192e6e1796 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | a6e9b316-549d-4058-8c08-407e4ce5c255 | 1 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 3c153389-4361-4a39-b7da-151ffc566f24 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-0484-01 | 00406048401 | 100 TABLET in 1 BOTTLE (0406-0484-01) | 100 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-03 | 00406048403 | 30 TABLET in 1 BOTTLE (0406-0484-03) | 30 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-10 | 00406048410 | 1000 TABLET in 1 BOTTLE (0406-0484-10) | 1000 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-20 | 00406048420 | 20 TABLET in 1 BOTTLE (0406-0484-20) | 20 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-23 | 00406048423 | 1 TABLET in 1 BLISTER PACK (0406-0484-23) | 1 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-50 | 00406048450 | 50 TABLET in 1 BOTTLE (0406-0484-50) | 50 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0484-62 | 00406048462 | 100 TABLET in 1 BLISTER PACK (0406-0484-62) | 100 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |