Misoprostol
- Product NDC
- 33261-076
- 11-digit product format
- 332610076
- Labeler code
- 33261
- Product ID
- 33261-076_384c955d-a727-43b5-be9e-3e6f501cf2d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA091667
- Marketing category
- ANDA
- Marketing start
- 2012-07-25
- Marketing end
- 0000-00-00
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 73109aa8-3e7c-b7a0-fb29-6f84db91e7d9 | Product name | 3 | 20231221 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-076-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-24de-f424-e053-dadaa90a57ce | Misoprostol Tablets GAVIS Pharmaceuticals, LLC |
| 33261-076-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-24de-f424-e053-dadaa90a57ce | Misoprostol Tablets GAVIS Pharmaceuticals, LLC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-076-13 | Misoprostol | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | 1 | |
| 33261-076-31 | Misoprostol | 3 in 1 BOTTLE, PLASTIC | TABLET | 3 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-076-13 | EA - Each | 33261-076 | 0085155b-f8e4-460b-b3ba-85541a37d515 | 1 | 2016-09-02 |
| 33261-076-31 | EA - Each | 33261-076 | 57ff99c9-d31c-4978-859c-70ff187ad97d | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MISOPROSTOL | ACTIVE INGREDIENT | 0E43V0BB57 | MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MISOPROSTOL | ACTIVE MOIETY | 0E43V0BB57 | MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | MISOPROSTOL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311727 | miSOPROStol 100 MCG Oral Tablet | PSN | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
| 317128 | miSOPROStol 200 MCG Oral Tablet | PSN | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
| 311727 | misoprostol 0.1 MG Oral Tablet | SCD | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
| 317128 | misoprostol 0.2 MG Oral Tablet | SCD | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
| 311727 | misoprostol 100 MCG Oral Tablet | SY | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
| 317128 | misoprostol 200 MCG Oral Tablet | SY | 4974780a-ca09-4c1e-b593-bfe17ca08480 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-076-13 | 33261007613 | 4 in 1 BOTTLE, PLASTIC | Historical |
| 33261-076-31 | 33261007631 | 3 in 1 BOTTLE, PLASTIC | Historical |