What is NDC 63629-8657?

63629-8657 is the product NDC for Flurandrenolide, Flurandrenolide .5 mg/mL lotion, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flurandrenolide?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flurandrenolide NDC 63629-8657 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8657Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8657Add 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
63629-8657-1	63629865701	1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTICMarketed from Oct 6, 2016

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): Flurandrenolide
Generic name (nonproprietary): flurandrenolide
Active ingredients: Flurandrenolide — .5 mg/mL
Dosage form: Lotion
Route: Topical
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207133
Marketing start: Oct 6, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-8657_00b804f5-7685-0b1d-e063-6294a90a5753SPL ID 00b804f5-7685-0b1d-e063-6294a90a5753SPL set ID 3868377d-bee3-42f4-8c72-319e84e7d5bdRxCUI 197719UNII 8EUL29XUQT
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

N463629865701 followed by a unit qualifier and the quantity

Package 63629-8657-01. 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 Jul 17, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8657

What is NDC 63629-8657?: 63629-8657 is the product NDC for Flurandrenolide, Flurandrenolide .5 mg/mL lotion, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flurandrenolide.
What is the active ingredient?: Flurandrenolide.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flurandrenolide?: 2 other product NDCs are listed under this name. See all Flurandrenolide 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 Flurandrenolide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Padagis Israel Pharmaceuticals Ltd	45802-928	45802-0928-03
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	72162-1439	72162-1439-02

Other NDCs under ANDA 207133

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

FDA NDC Directory listings under ANDA 207133
Product	Strength	Form · route	Labeler	Product NDC
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Padagis Israel Pharmaceuticals Ltd	45802-928
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	72162-1439