ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 0406-0485
- 11-digit product format
- 004060485
- Labeler code
- 0406
- Product ID
- 0406-0485_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; 60 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040419-001 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040419-002 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040419-003 | AA | 1 | a50c72e98297… |
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 | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 0406-0485 |
| 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 |
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 | 60 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 |
|---|---|---|---|---|---|---|
| 0406-0485-01 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 100 in 1 BOTTLE | TABLET | 100 | 50 | |
| 0406-0485-05 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 500 in 1 BOTTLE | TABLET | 500 | 50 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-0485-01 | EA - Each | 0406-0485 | cb02357c-fec1-471b-b40a-0aaa4a132c5f | 1 | 2012-07-24 |
| 0406-0485-05 | EA - Each | 0406-0485 | a7b48515-f05e-4d22-a524-96b8eb204765 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 1012 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 1012 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 1012 |
| 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 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 18 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 18 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 18 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 6 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 6 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 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 | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 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 |
| 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 | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 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 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 5603ed2f-0b6c-46fd-8c76-c4e4d188a343 | 3 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 5603ed2f-0b6c-46fd-8c76-c4e4d188a343 | 3 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 5603ed2f-0b6c-46fd-8c76-c4e4d188a343 | 3 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | e78e50c0-36da-528e-e053-2995a90a3d80 | 2 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | e78e50c0-36da-528e-e053-2995a90a3d80 | 2 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | e78e50c0-36da-528e-e053-2995a90a3d80 | 2 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | e42fa7d2-47f0-0e82-e053-2995a90a67c5 | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | e42fa7d2-47f0-0e82-e053-2995a90a67c5 | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | e42fa7d2-47f0-0e82-e053-2995a90a67c5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-0485-01 | 00406048501 | 100 TABLET in 1 BOTTLE (0406-0485-01) | 100 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |
| 0406-0485-05 | 00406048505 | 500 TABLET in 1 BOTTLE (0406-0485-05) | 500 tablet | 2001-05-31 | 0000-00-00 | No | No | Current |