What is NDC 42291-510?

42291-510 is the product NDC for Primaquine Phosphate, Primaquine phosphate 15 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Primaquine Phosphate NDC 42291-510 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0510Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-510-01	42291051001	100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01)Marketed from Feb 21, 2019

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: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206043
Marketing start: Feb 21, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 42291-510_4ba945a5-47a2-e791-e063-6294a90a9f8aSPL ID 4ba945a5-47a2-e791-e063-6294a90a9f8aSPL set ID 82465385-4602-7f46-e053-2991aa0a9fdfRxCUI 904170UNII H0982HF78B
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

N442291051001 followed by a unit qualifier and the quantity

Package 42291-0510-01. 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 Feb 25, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-510

What is NDC 42291-510?: 42291-510 is the product NDC for Primaquine Phosphate, Primaquine phosphate 15 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, 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?: AvKARE, NDC labeler code 42291. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Primaquine Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-721	43063-0721-1443063-0721-28
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.

FDA NDC Directory listings under ANDA 206043
Product	Strength	Form · route	Labeler	Product NDC
Primaquine Phosphate	Primaquine phosphate 15 mg/1	Tablet, Film coatedOral	Ingenus Pharmaceuticals, LLC	50742-191