Codeine Sulfate
- Product NDC
- 0527-1727
- 11-digit product format
- 005271727
- Labeler code
- 0527
- Product ID
- 0527-1727_aa8c1550-c22e-4945-8664-7a3d66523843
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Codeine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA203046
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Substance
- CODEINE SULFATE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Codeine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CODEINE SULFATE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 11QV9BS0CB |
| Rxcui | 997170, 997287, 997296 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0527-1727-91 | 2020-08-27 | C162847 | 48780-1 | ab0e2407-2920-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, USP, for oral use CII Initial U.S. Approval: 1950 |
| 0527-1727-91 | 2020-08-27 | C162847 | 48780-1 | ab0e2407-2920-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, USP, for oral use CII Initial U.S. Approval: 1950 |
| 0527-1727-91 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2920-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, USP, for oral use CII Initial U.S. Approval: 1950 |
| 0527-1727-91 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2920-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, USP, for oral use CII Initial U.S. Approval: 1950 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1727-91 | Codeine Sulfate | 4 in 1 CARTON | TABLET | 4 | | 29 |
| 0527-1727-91 | Codeine Sulfate | 25 in 1 BLISTER PACK | TABLET | 25 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CODEINE SULFATE | ACTIVE INGREDIENT | 11QV9BS0CB | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] | 6 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0527-1727-91 | 00527172791 | 4 BLISTER PACK in 1 CARTON (0527-1727-91) / 25 TABLET in 1 BLISTER PACK | 4 blister pack | 2014-06-13 | No | No | Historical |