What is NDC 63629-8656?

63629-8656 is the product NDC for Fluocinolone acetonide, Fluocinolone acetonide .01 mg/100mL oil, 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 Fluocinolone acetonide?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluocinolone acetonide NDC 63629-8656

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8656Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8656Add 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
63629-8656-1	6362986560163629865601	1 BOTTLE in 1 CARTON (63629-8656-1) / 118.28 mL in 1 BOTTLEMarketed from Jun 14, 2017

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): Fluocinolone acetonide
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .01 mg/100mL
Dosage form: Oil
Route: Topical
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202848
Marketing start: Jun 14, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-8656_fc6d4410-b1a1-4a02-a893-2448c8c215a0SPL ID fc6d4410-b1a1-4a02-a893-2448c8c215a0SPL set ID c9e2b99e-1f64-4c21-99a7-a18963be2237UNII 0CD5FD6S2M
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

N463629865601 followed by a unit qualifier and the quantity

Package 63629-8656-01. 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 May 24, 2024.

Indications (excerpt from the label)

INDICATION AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8656

What is NDC 63629-8656?: 63629-8656 is the product NDC for Fluocinolone acetonide, Fluocinolone acetonide .01 mg/100mL oil, 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?: Fluocinolone acetonide.
What is the active ingredient?: Fluocinolone acetonide.
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 Fluocinolone acetonide?: 31 other product NDCs are listed under this name. See all Fluocinolone acetonide 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 Fluocinolone acetonide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
fluocinolone acetonide	Fluocinolone acetonide .1 mg/g	CreamTopical	ANI Pharmaceuticals, Inc.	62559-288	62559-0288-1562559-0288-60
fluocinolone acetonide	Fluocinolone acetonide .25 mg/g	CreamTopical	ANI Pharmaceuticals, Inc.	62559-289	62559-0289-1562559-0289-60
Fluocinolone Acetonide	Fluocinolone acetonide .25 mg/g	OintmentTopical	ANI Pharmaceuticals, Inc.	62559-299	62559-0299-1562559-0299-60
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Quagen Pharmaceuticals LLC	70752-156	70752-0156-06
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Quagen Pharmaceuticals LLC	70752-158	70752-0158-06
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilAuricular (Otic)	Quagen Pharmaceuticals LLC	70752-159	70752-0159-20
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilAuricular (Otic)	Bryant Ranch Prepack	71335-2879	71335-2879-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	71335-2883	71335-2883-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	71335-2884	71335-2884-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	72162-2319	72162-2319-02

All 32 Fluocinolone acetonide NDCs

Other NDCs under ANDA 202848

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

FDA NDC Directory listings under ANDA 202848
Product	Strength	Form · route	Labeler	Product NDC
Fluocinolone acetonide	Fluocinolone acetonide .01 mg/100mL	OilTopical	Padagis Israel Pharmaceuticals Ltd	45802-485
Fluocinolone acetonide	Fluocinolone acetonide .01 mg/100mL	OilTopical	A-S Medication Solutions	50090-7958
Fluocinolone acetonide	Fluocinolone acetonide .01 mg/100mL	OilTopical	Bryant Ranch Prepack	72162-1412