Primaquine Phosphate NDC 76385-102

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-102Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0102Add 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
76385-102-01	76385010201	100 TABLET in 1 BOTTLE (76385-102-01)Marketed from Aug 1, 2014

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: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204476
Marketing start: Aug 1, 2014
Listing expires: Dec 31, 2027
Identifiers: Product ID 76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3SPL ID 8199ccba-1a57-43f1-bbdc-70b6720b72c3SPL set ID 0c8c2bc6-428b-40b6-8114-6df80290878dRxCUI 904170UNII H0982HF78BUPC 0376385102012
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

N476385010201 followed by a unit qualifier and the quantity

Package 76385-0102-01. 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 Tablets are 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)

Other NDCs under ANDA 204476

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204476
Product	Strength	Form · route	Labeler	Product NDC
Primaquine Phosphate	Primaquine phosphate 15 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-721