Prescription drug · ANDA
Primaquine Phosphate NDC 43063-721
Primaquine phosphate 15 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-721-14 | 43063072114 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)Marketed from Oct 17, 2016 | |
| 43063-721-28 | 43063072128 | 28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28)Marketed from Oct 17, 2016 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204476
- Marketing start
- Listing expires
- Identifiers
- Product ID 43063-721_51a584d0-f172-e260-e063-6394a90a4547SPL ID 51a584d0-f172-e260-e063-6394a90a4547SPL set ID 3f16166d-678e-51aa-e054-00144ff88e88RxCUI 904170UNII H0982HF78BUPC 0343063721285
- 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
N443063072114followed by a unit qualifier and the quantityPackage 43063-0721-14. 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 Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.
Excerpt only. Read the full label for complete information.
About NDC 43063-721
- What is NDC 43063-721?
- 43063-721 is the product NDC for Primaquine Phosphate, Primaquine phosphate 15 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-191 | 50742-0191-0150742-0191-05 |
| 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 204476
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 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-102 |