Docosanol NDC 51316-763

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-763Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0763Add 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
51316-763-02	51316076302	1 TUBE in 1 PACKAGE (51316-763-02) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-03	51316076303	2 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-04	51316076304	1 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-62	51316076362	1 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMPMarketed from May 23, 2024
51316-763-64	51316076364	1 BOTTLE, PUMP in 1 PACKAGE (51316-763-64) / 2 g in 1 BOTTLE, PUMPMarketed from May 23, 2024

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): Docosanol
Generic name (nonproprietary): docosanol
Active ingredients: Docosanol — 100 mg/g
Dosage form: Cream
Route: Topical
Labeler: CVS Pharmacy, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215839
Marketing start: May 23, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 51316-763_a5f62764-d8f4-4d2e-8fa1-cd05b61cc48fSPL ID a5f62764-d8f4-4d2e-8fa1-cd05b61cc48fSPL set ID 336b515c-5e7b-4ece-a94f-f8d8e9ce6a7bRxCUI 797534UNII 9G1OE216XY

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N451316076302 followed by a unit qualifier and the quantity

Package 51316-0763-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215839

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

FDA NDC Directory listings under ANDA 215839
Product	Strength	Form · route	Labeler	Product NDC
Docosanol	Docosanol 100 mg/g	CreamTopical	Rugby Laboratories	0536-1427
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-682
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-682
Docosanol	Docosanol 100 mg/g	CreamTopical	Leader/ Cardinal Health 110, Inc.	70000-0672
Docosanol	Docosanol 100 mg/g	CreamTopical	Cosette Pharmaceuticals, Inc.	0713-0353
Docosanol	Docosanol 100 mg/g	CreamTopical	Leader/ Cardinal Health 110, Inc.	70000-0743