MORPHINE SULFATE
- Product NDC
- 67877-671
- 11-digit product format
- 678770671
- Labeler code
- 67877
- Product ID
- 67877-671_2d263950-4148-405d-b582-13857ac88044
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA212451
- Marketing category
- ANDA
- Marketing start
- 2021-02-11
- Substance
- MORPHINE SULFATE
- Active strength
- 30 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
- MORPHINE SULFATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MORPHINE SULFATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 892582, 892672 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67877-671-01 | 2025-05-13 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2025-05-13 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2024-07-30 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2024-07-30 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2022-09-16 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2022-09-16 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
| 67877-671-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-abb4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-671-01 | MORPHINE SULFATE | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-671 | MORPHINE SULFATE TABLET [ASCEND LABORATORIES, LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20250515_07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a.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 |
|---|
| 67877-671-01 | 67877067101 | 100 TABLET in 1 BOTTLE (67877-671-01) | 100 tablet | 2021-02-11 | 0000-00-00 | No | No | Current |