What is NDC 45802-078?

45802-078 is the product NDC for Brimonidine, Brimonidine tartrate 5 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 45802-078 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0078Add 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
45802-078-30	4580200783045802007830	1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMPMarketed from Jan 1, 2023

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): Brimonidine
Generic name (nonproprietary): brimonidine
Active ingredients: Brimonidine tartrate — 5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
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 45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75SPL ID 6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75SPL set ID c899b329-cc5e-4443-8e94-451314de47c9RxCUI 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

N445802007830 followed by a unit qualifier and the quantity

Package 45802-0078-30. 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 31, 2024.

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 45802-078

What is NDC 45802-078?: 45802-078 is the product NDC for Brimonidine, Brimonidine tartrate 5 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. 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?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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	Bryant Ranch Prepack	63629-9616	63629-9616-01

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	Bryant Ranch Prepack	63629-9616