Morphine sulfate
- Product NDC
- 0228-4323
- 11-digit product format
- 002284323
- Labeler code
- 0228
- Product ID
- 0228-4323_b3ebf58d-9730-4a88-802c-5c27fb2b090f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203849
- Marketing category
- ANDA
- Marketing start
- 2015-10-26
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-4323-11 | Morphine sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) | INACTIVE INGREDIENT | 12VCE9HR9E | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-4323 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 19 | Legacy NDC, 1 package rows | 20240604_75fb4282-0bbd-4d63-a7d1-5142780a4fae.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 |
|---|
| 0228-4323-11 | 00228432311 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4323-11) | 2015-10-26 | 0000-00-00 | No | No | Current |