Diclofenac sodium and Misoprostol
- Product NDC
- 59762-0028
- 11-digit product format
- 597620028
- Labeler code
- 59762
- Product ID
- 59762-0028_540456cf-d8d4-4c2f-883d-933c5d0b862b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac sodium and Misoprostol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020607
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-11-01
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 50; 200 mg/1; ug/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac sodium and Misoprostol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 mg/1 |
| MISOPROSTOL | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57, QTG126297Q |
| Rxcui | 857706, 1359105 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59762-0028-1 | Diclofenac sodium and Misoprostol | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 23 |
| 59762-0028-2 | Diclofenac sodium and Misoprostol | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| MISOPROSTOL | ACTIVE INGREDIENT | 0E43V0BB57 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| MISOPROSTOL | ACTIVE MOIETY | 0E43V0BB57 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-0028 | DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20250524_a7701e8c-4e16-4165-8b83-de2c08d5ded3.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 |
|---|
| 59762-0028-1 | 59762002801 | 60 TABLET, FILM COATED in 1 BOTTLE (59762-0028-1) | 2012-11-01 | 0000-00-00 | No | No | Current |
| 59762-0028-2 | 59762002802 | 90 TABLET, FILM COATED in 1 BOTTLE (59762-0028-2) | 2012-11-01 | 0000-00-00 | No | No | Current |