Morphine Sulfate
- Product NDC
- 63629-8505
- 11-digit product format
- 636298505
- Labeler code
- 63629
- Product ID
- 63629-8505_653ac87e-a9f4-4f67-9ebf-1f3cfae6e38e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA074769
- Marketing category
- ANDA
- Marketing start
- 2011-01-14
- Substance
- MORPHINE SULFATE
- Active strength
- 200 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
- Morphine Sulfate
- Brand name suffix
- Extended Release
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MORPHINE SULFATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 892646 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8505-1 | Morphine SulfateExtended Release | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 100 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8505 | MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20240418_2dd52157-3121-41ed-abc2-99b269531e56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8505-1 | 63629850501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8505-1) | 2024-04-04 | 0000-00-00 | No | No | Current |