Codeine sulfate
- Product NDC
- 0054-0243
- 11-digit product format
- 000540243
- Labeler code
- 0054
- Product ID
- 0054-0243_b04f74f8-d960-4b7a-988a-372d9a1e1406
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- codeine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA022402
- Marketing category
- NDA
- Marketing start
- 2009-07-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Codeine sulfate
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0243-24 | Codeine sulfate | 10 in 1 BOX | TABLET | 10 | | 25 |
| 0054-0243-24 | Codeine sulfate | 10 in 1 BLISTER PACK | TABLET | 10 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0243 | CODEINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 24 | Current NDC, Legacy NDC, 2 package rows | 20231220_010905f9-3bcb-4b50-9fe8-a3ad0010f14c.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 |
|---|
| 0054-0243-24 | 00054024324 | 10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2009-07-16 | 0000-00-00 | No | No | Current |