Prescription drug · ANDA
Primaquine Phosphate NDC 50742-191
Primaquine phosphate 15 mg/1 · Tablet, Film coated · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-191-01 | 50742019101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)Marketed from Jan 23, 2018 | |
| 50742-191-05 | 50742019105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)Marketed from Jan 23, 2018 |
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)
- Primaquine Phosphate
- Generic name (nonproprietary)
- primaquine phosphate
- Active ingredients
- Primaquine phosphate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206043
- Marketing start
- Listing expires
- Identifiers
- Product ID 50742-191_0d416a06-fb95-4a01-97c8-02e28ee99c2aSPL ID 0d416a06-fb95-4a01-97c8-02e28ee99c2a
- Pharmacologic class
- Antimalarial
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
N450742019101followed by a unit qualifier and the quantityPackage 50742-0191-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50742-191
- What is NDC 50742-191?
- 50742-191 is the product NDC for Primaquine Phosphate, Primaquine phosphate 15 mg/1 tablet, film coated, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Primaquine Phosphate.
- What is the active ingredient?
- Primaquine phosphate.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Primaquine Phosphate?
- 4 other product NDCs are listed under this name. See all Primaquine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Primaquine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Primaquine Phosphate | Primaquine phosphate 15 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-510 | 42291-0510-01 |
| Primaquine Phosphate | Primaquine phosphate 15 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-721 | 43063-0721-1443063-0721-28 |
| Primaquine Phosphate | Primaquine phosphate 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-102 | 76385-0102-01 |
| Primaquine Phosphate | Primaquine phosphate 15 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-1596 | 00024-1596-01 |
Other NDCs under ANDA 206043
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 |
|---|---|---|---|---|
| Primaquine Phosphate | Primaquine phosphate 15 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-510 |