What is NDC 63629-9616?

63629-9616 is the product NDC for Brimonidine, Brimonidine tartrate 5 mg/g gel, 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 Brimonidine?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Brimonidine NDC 63629-9616 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-9616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-9616Add 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
63629-9616-1	6362996160163629961601	1 BOTTLE, PUMP in 1 CARTON (63629-9616-1) / 30 g in 1 BOTTLE, PUMPMarketed from Feb 3, 2023

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): Brimonidine
Generic name (nonproprietary): brimonidine
Active ingredients: Brimonidine tartrate — 5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209158
Marketing start: Jan 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 63629-9616_ee63f0f9-fb9a-4151-9e1b-3e8f2e8c2ee4SPL ID ee63f0f9-fb9a-4151-9e1b-3e8f2e8c2ee4SPL set ID 9f17bf0c-d880-4328-bf92-00ac81d02fd1RxCUI 1437707UNII 4S9CL2DY2H
Pharmacologic class: alpha-Adrenergic Agonist

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

N463629961601 followed by a unit qualifier and the quantity

Package 63629-9616-01. 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 Feb 3, 2023.

Indications (excerpt from the label)

Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-9616

What is NDC 63629-9616?: 63629-9616 is the product NDC for Brimonidine, Brimonidine tartrate 5 mg/g gel, 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?: Brimonidine.
What is the active ingredient?: Brimonidine tartrate.
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 Brimonidine?: 2 other product NDCs are listed under this name. See all Brimonidine 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 Brimonidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Brimonidinebrimonidine tartrate	Brimonidine tartrate 1 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	0781-7177	00781-7177-7000781-7177-7500781-7177-85
Brimonidine	Brimonidine tartrate 5 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-078	45802-0078-30

Other NDCs under ANDA 209158

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

FDA NDC Directory listings under ANDA 209158
Product	Strength	Form · route	Labeler	Product NDC
Brimonidine	Brimonidine tartrate 5 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-078