Acetaminophen and Codeine
- Product NDC
- 53002-0101
- 11-digit product format
- 530020101
- Labeler code
- 53002
- Product ID
- 53002-0101_f7b0f711-4eae-4662-8860-3029fb2f366d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040779
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-0101-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-5 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-5 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-5 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-1 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-2 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-3 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-5 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
| 53002-0101-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14a3-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0101-1 | Acetaminophen and Codeine | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 53002-0101-2 | Acetaminophen and Codeine | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 53002-0101-3 | Acetaminophen and Codeine | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 53002-0101-5 | Acetaminophen and Codeine | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0101 | ACETAMINOPHEN AND CODEINE TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_5970383b-06a3-45e7-9e93-41213a4f9b5d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-0101-1 | 53002010101 | 10 TABLET in 1 BOTTLE (53002-0101-1) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-0101-2 | 53002010102 | 20 TABLET in 1 BOTTLE (53002-0101-2) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-0101-3 | 53002010103 | 30 TABLET in 1 BOTTLE (53002-0101-3) | 30 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-0101-5 | 53002010105 | 15 TABLET in 1 BOTTLE (53002-0101-5) | 15 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |