Morphine Sulfate
- Product NDC
- 58177-380
- 11-digit product format
- 581770380
- Labeler code
- 58177
- Product ID
- 58177-380_44b9cb00-c457-4cc3-99e3-0db1be101fcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ETHEX Corporation
- Application
- ANDA077855
- Marketing category
- ANDA
- Marketing start
- 2009-01-01
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 58177-380-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d260-621f-e053-dbdaa90a74ad | CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg* |
| 58177-380-09 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d260-621f-e053-dbdaa90a74ad | CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg* |
| 58177-380-11 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d260-621f-e053-dbdaa90a74ad | CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg* |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58177-380-04 | Morphine Sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 5 |
| 58177-380-09 | Morphine Sulfate | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 5 |
| 58177-380-11 | Morphine Sulfate | 100 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 100 | | 5 |
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 [ETHEX CORPORATION] | 5 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58177-380 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION] | 5 | Legacy NDC, 3 package rows | 20100521_1a2c9474-fab6-41a0-844d-d6bd5e6a4341.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58177-380-04 | 58177038004 | 100 in 1 BOTTLE | Historical |
| 58177-380-09 | 58177038009 | 1000 in 1 BOTTLE | Historical |
| 58177-380-11 | 58177038011 | 100 in 1 BLISTER PACK | Historical |