Acetaminophen And Codeine
- Product NDC
- 67296-0544
- 11-digit product format
- 672960544
- Labeler code
- 67296
- Product ID
- 67296-0544_980307ab-36fe-453a-b5e4-eaf528919dd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- ANDA089805
- Marketing category
- ANDA
- Marketing start
- 1988-09-30
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 20c8cafe-5cfc-44f8-a9be-a664f437f780 | Product name | 2 | 20200225 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 47fd879b-91c5-e1e5-130f-29d082a871ec | Product name | 1 | 20140508 |
| c35d1ac8-8885-2ee1-6c52-5a715b242c00 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-0544-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cd22-8e05-e053-dbdaa90a074a | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg |
| 67296-0544-2 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cd22-8e05-e053-dbdaa90a074a | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg |
| 67296-0544-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cd22-8e05-e053-dbdaa90a074a | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0544-1 | Acetaminophen And Codeine | 15 in 1 BOTTLE | TABLET | 15 | 8 | |
| 67296-0544-2 | Acetaminophen And Codeine | 30 in 1 BOTTLE | TABLET | 30 | 8 | |
| 67296-0544-3 | Acetaminophen And Codeine | 20 in 1 BOTTLE | TABLET | 20 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0544 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [REDPHARM DRUG INC.] | 8 | Legacy NDC, 3 package rows | 20110608_65921b50-5215-41cc-91b9-ac5ea6282bb1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 65921b50-5215-41cc-91b9-ac5ea6282bb1 | 8 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 65921b50-5215-41cc-91b9-ac5ea6282bb1 | 8 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 65921b50-5215-41cc-91b9-ac5ea6282bb1 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 67296-0544-1 | 67296054401 | 15 in 1 BOTTLE | Historical |
| 67296-0544-2 | 67296054402 | 30 in 1 BOTTLE | Historical |
| 67296-0544-3 | 67296054403 | 20 in 1 BOTTLE | Historical |