NDC codes

FDA NDC Directory
Product NDC (as listed)51672-1258Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-1258Add 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
51672-1258-151672125801516721258011 TUBE in 1 CARTON (51672-1258-1) / 15 g in 1 TUBEMarketed from Jul 8, 1996
51672-1258-251672125802516721258021 TUBE in 1 CARTON (51672-1258-2) / 30 g in 1 TUBEMarketed from Jul 8, 1996
51672-1258-351672125803516721258031 TUBE in 1 CARTON (51672-1258-3) / 60 g in 1 TUBEMarketed from Jul 8, 1996
51672-1258-651672125806516721258061 TUBE in 1 CARTON (51672-1258-6) / 45 g in 1 TUBEMarketed from Jul 8, 1996

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Clobetasol Propionate
Generic name (nonproprietary)
clobetasol propionate
Active ingredients
Clobetasol propionate — .5 mg/g
Dosage form
Cream
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074249
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 51672-1258_4db5c318-4c64-4e2c-e063-6294a90aa7f9SPL ID 4db5c318-4c64-4e2c-e063-6294a90aa7f9SPL set ID 4a761afb-a48a-4a5a-8700-ad93601a260fRxCUI 861434, 861448, 861495UNII 779619577MUPC 0351672129422
Pharmacologic class
Corticosteroid

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

N451672125801 followed by a unit qualifier and the quantity

Package 51672-1258-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be neces…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1258

What is NDC 51672-1258?
51672-1258 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clobetasol Propionate.
What is the active ingredient?
Clobetasol propionate.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clobetasol Propionate?
96 other product NDCs are listed under this name. See all Clobetasol Propionate 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 Clobetasol Propionate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clobetasol PropionateClobetasol propionate .5 mg/gOintmentTopicalA-S Medication Solutions50090-800150090-8001-00
Clobetasol PropionateClobetasol propionate .5 mg/gOintmentTopicalNorthStar RxLLC72603-85572603-0855-0172603-0855-0272603-0855-03+1 more
Clobetasol PropionateClobetasol propionate .5 mg/gAerosol, FoamTopicalAlembic Pharmaceuticals Limited46708-70746708-0707-3146708-0707-50
Clobetasol PropionateClobetasol propionate .5 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-54746708-0547-1546708-0547-3046708-0547-45+1 more
Clobetasol PropionateClobetasol propionate .05 g/100mLShampooTopicalAlembic Pharmaceuticals Limited46708-54846708-0548-04
Clobetasol PropionateClobetasol propionate .5 mg/mLSolutionTopicalAlembic Pharmaceuticals Limited46708-48646708-0486-2546708-0486-50
Clobetasol PropionateClobetasol propionate .05 g/mLSprayTopicalAlembic Pharmaceuticals Limited46708-42546708-0425-1246708-0425-59
Clobetasol PropionateClobetasol propionate .5 mg/gOintmentTopicalAlembic Pharmaceuticals Limited46708-46546708-0465-1546708-0465-3046708-0465-45+1 more
Clobetasol PropionateClobetasol propionate .25 mg/gCreamTopicalINA Pharmaceutics Inc74157-71074157-0710-10
Clobetasol PropionateClobetasol propionate .5 mg/gCreamTopicalTorrent Pharmaceuticals Limited13668-56913668-0569-0113668-0569-0213668-0569-04+1 more

All 97 Clobetasol Propionate NDCs

Other NDCs under ANDA 074249

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

FDA NDC Directory listings under ANDA 074249
ProductStrengthForm · routeLabelerProduct NDC
Clobetasol PropionateClobetasol propionate .5 mg/gCreamTopicalA-S Medication Solutions50090-0549

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