Prescription drug · ANDA
Methyldopa NDC 64980-571
Methyldopa 250 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-571-01 | 64980057101 | 100 TABLET in 1 BOTTLE (64980-571-01)Marketed from Apr 4, 2025 |
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)
- Methyldopa
- Generic name (nonproprietary)
- methyldopa
- Active ingredients
- Methyldopa — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070076
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 64980-571_807ace4b-b2af-44b4-9371-884d73e21601SPL ID 807ace4b-b2af-44b4-9371-884d73e21601SPL set ID 9e22e1d8-04ec-4b67-92ea-b09c706f2703RxCUI 197956, 197958UNII 56LH93261Y
- Pharmacologic class
- Central alpha-2 Adrenergic Agonist
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
N464980057101followed by a unit qualifier and the quantityPackage 64980-0571-01. 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 & USAGE Hypertension.
Excerpt only. Read the full label for complete information.
About NDC 64980-571
- What is NDC 64980-571?
- 64980-571 is the product NDC for Methyldopa, Methyldopa 250 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methyldopa.
- What is the active ingredient?
- Methyldopa.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methyldopa?
- 3 other product NDCs are listed under this name. See all Methyldopa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methyldopa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methyldopa | Methyldopa 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-572 | 64980-0572-01 |
| Methyldopa | Methyldopa 250 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-321 | 62135-0321-1862135-0321-90 |
| Methyldopa | Methyldopa 500 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-322 | 62135-0322-1862135-0322-90 |
Other NDCs under ANDA 070076
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methyldopa | Methyldopa 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-572 |