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 NDC11-digit (billing)PackageCopy
51316-763-0251316076302513160763021 TUBE in 1 PACKAGE (51316-763-02) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-0351316076303513160763032 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-0451316076304513160763041 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBEMarketed from May 23, 2024
51316-763-6251316076362513160763621 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMPMarketed from May 23, 2024
51316-763-6451316076364513160763641 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.NDC labeler code 51316
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215839
Marketing start
Listing expires
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

Current FDA label (SPL), effective .

Full label on DailyMed (opens in a new tab)

About NDC 51316-763

What is NDC 51316-763?
51316-763 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by CVS Pharmacy, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Docosanol.
What is the active ingredient?
Docosanol.
Who is the labeler?
CVS Pharmacy, Inc., NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Docosanol?
35 other product NDCs are listed under this name. See all Docosanol 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 Docosanol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DocosanolDocosanol 100 mg/gCreamTopicalBIONPHARMA INC.69452-55069452-0550-0269452-0550-61
DocosanolDocosanol 100 mg/gCreamTopicalDr.Reddys' Laboratories Inc43598-94643598-0946-0243598-0946-1343598-0946-22
DocosanolDocosanol 100 mg/gCreamTopicalDr.Reddys' Laboratories Inc43598-04443598-0044-0243598-0044-33
DocosanolDocosanol 100 mg/gCreamTopicalKLM Laboratories Private Limited84725-00184725-0001-0184725-0001-0284725-0001-09
DocosanolDocosanol 100 mg/gCreamTopicalLeader/ Cardinal Health 110, Inc.70000-074370000-0743-01
DocosanolDocosanol 100 mg/gCreamTopicalWALMART INC. (see also Equate)79903-40279903-0402-1079903-0402-20
DocosanolDocosanol 100 mg/gCreamTopicalPublix Super Markets Inc.41415-66041415-0660-03
DocosanolDocosanol 100 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-68246708-0682-0146708-0682-03
DocosanolDocosanol 100 mg/gCreamTopicalH2-Pharma, LLC61269-88161269-0881-35
DocosanolDocosanol 100 mg/gCreamTopicalYYBA Corp73581-00473581-0004-0273581-0004-0373581-0004-10+1 more

All 36 Docosanol NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
DocosanolDocosanol 100 mg/gCreamTopicalRugby Laboratories0536-1427
DocosanolDocosanol 100 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-0353
DocosanolDocosanol 100 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-682
DocosanolDocosanol 100 mg/gCreamTopicalAlembic Pharmaceuticals Inc.62332-682
DocosanolDocosanol 100 mg/gCreamTopicalLeader/ Cardinal Health 110, Inc.70000-0672
DocosanolDocosanol 100 mg/gCreamTopicalLeader/ Cardinal Health 110, Inc.70000-0743

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