NDC 46708-661

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-661Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0661Add 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
46708-661-05	46708066105	1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLEMarketed from Mar 29, 2023
46708-661-10	46708066110	1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLEMarketed from Mar 29, 2023
46708-661-15	46708066115	1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLEMarketed from Mar 29, 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 Tartrate ophthalmic solution, 0.15%
Generic name (nonproprietary): brimonidine tartrate ophthalmic solution, 0.15%
Active ingredients: Brimonidine tartrate — 1.5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215225
Marketing start: Mar 29, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820bSPL ID e1ea003e-3dd9-41c7-9119-d1f209b9820bSPL set ID e1ea003e-3dd9-41c7-9119-d1f209b9820bRxCUI 861208UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N446708066105 followed by a unit qualifier and the quantity

Package 46708-0661-05. 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 6, 2023.

Indications (excerpt from the label)

Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215225

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

FDA NDC Directory listings under ANDA 215225
Product	Strength	Form · route	Labeler	Product NDC
Brimonidine Tartrate ophthalmic solution, 0.15%	Brimonidine tartrate 1.5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-661

Brimonidine Tartrate ophthalmic solution, 0.15% NDC 46708-661