Methylergonovine Maleate
- Product NDC
- 83400-100
- 11-digit product format
- 834000100
- Labeler code
- 83400
- Product ID
- 83400-100_24b0446f-9cfa-4544-b677-8ff15e98ebcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylergonovine maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Volley Pharmaceuticals, LLC
- Application
- ANDA212233
- Marketing category
- ANDA
- Marketing start
- 2024-03-15
- Substance
- METHYLERGONOVINE MALEATE
- Active strength
- .2 mg/1
- Pharmacologic classes
- Ergolines [CS], Ergot Derivative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylergonovine Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLERGONOVINE MALEATE | .2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IR84JPZ1RK |
| Rxcui | 996824 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83400-100-12 | Methylergonovine Maleate | 12 in 1 BOTTLE | TABLET | 12 | | 1 |
| 83400-100-28 | Methylergonovine Maleate | 28 in 1 BOTTLE | TABLET | 28 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83400-100 | METHYLERGONOVINE MALEATE TABLET [VOLLEY PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20240323_0a318b77-d280-4571-992f-82e2e0a57c9b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83400-100-12 | 83400010012 | 12 TABLET in 1 BOTTLE (83400-100-12) | 12 tablet | 2024-03-15 | No | No | Current |
| 83400-100-28 | 83400010028 | 28 TABLET in 1 BOTTLE (83400-100-28) | 28 tablet | 2024-03-15 | No | No | Current |