Prescription drug · ANDA
Methylergonovine Maleate NDC 83400-100
Methylergonovine maleate .2 mg/1 · Tablet · Oral · Volley Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83400-100-12 | 83400010012 | 12 TABLET in 1 BOTTLE (83400-100-12)Marketed from Mar 15, 2024 | |
| 83400-100-28 | 83400010028 | 28 TABLET in 1 BOTTLE (83400-100-28)Marketed from Mar 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methylergonovine Maleate
- Generic name (nonproprietary)
- methylergonovine maleate
- Active ingredients
- Methylergonovine maleate — .2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Volley Pharmaceuticals, LLCNDC labeler code 83400
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212233
- Marketing start
- Listing expires
- Other FDA classes
- Ergolines (Chemical structure)
- Identifiers
- Product ID 83400-100_24b0446f-9cfa-4544-b677-8ff15e98ebcdSPL ID 24b0446f-9cfa-4544-b677-8ff15e98ebcdSPL set ID 0a318b77-d280-4571-992f-82e2e0a57c9bRxCUI 996824UNII IR84JPZ1RKUPC 0383400100120
- Pharmacologic class
- Ergot Derivative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483400010012followed by a unit qualifier and the quantityPackage 83400-0100-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
Excerpt only. Read the full label for complete information.
About NDC 83400-100
- What is NDC 83400-100?
- 83400-100 is the product NDC for Methylergonovine Maleate, Methylergonovine maleate .2 mg/1 tablet, listed with the FDA by Volley Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylergonovine Maleate.
- What is the active ingredient?
- Methylergonovine maleate.
- Who is the labeler?
- Volley Pharmaceuticals, LLC, NDC labeler code 83400. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylergonovine Maleate?
- 13 other product NDCs are listed under this name. See all Methylergonovine Maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylergonovine Maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7282 | 00904-7282-10 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/1 | TabletOral | American Health Packaging | 60687-813 | 60687-0813-94 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1556 | 51662-1556-02 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-735 | 16571-0735-0116571-0735-1716571-0735-21+1 more |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3655 | 00093-3655-2200093-3655-28 |
| Methylergonovine Maleatemethylergonovine | Methylergonovine maleate .2 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1605 | 69238-1605-0269238-1605-08 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-786 | 70010-0786-1270010-0786-28 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/mL | InjectionIntravenous | Breckenridge Pharmaceutical, Inc. | 51991-144 | 51991-0144-17 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/mL | InjectionIntravenous | Bryant Ranch Prepack | 63629-2074 | 63629-2074-01 |
| Methylergonovine Maleate | Methylergonovine maleate .2 mg/mL | InjectionIntravenous | Bryant Ranch Prepack | 72162-1592 | 72162-1592-02 |