Brimonidine Tartrate NDC 14445-400

NDC codes

FDA NDC Directory

Product NDC (as listed)14445-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width14445-0400Add 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
14445-400-05	14445040005	5 mg in 1 BOTTLE, PLASTIC (14445-400-05)Marketed from Jan 1, 2015
14445-400-10	14445040010	10 mg in 1 BOTTLE, PLASTIC (14445-400-10)Marketed from Jan 1, 2015
14445-400-15	14445040015	15 mg in 1 BOTTLE, PLASTIC (14445-400-15)Marketed from Jan 1, 2015

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
Generic name (nonproprietary): brimonidine tartrate
Active ingredients: Brimonidine tartrate — 2 mg/mg
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Indoco Remedies Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091691
Marketing start: Jan 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71SPL ID 383421a5-5d33-4f15-88f4-8b66fcbfac71SPL set ID 383421a5-5d33-4f15-88f4-8b66fcbfac71RxCUI 861200UNII 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

N414445040005 followed by a unit qualifier and the quantity

Package 14445-0400-05. 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 Dec 27, 2018.

Indications (excerpt from the label)

Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored. Brimonidine Tartrate Ophthalmic Solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091691

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

FDA NDC Directory listings under ANDA 091691
Product	Strength	Form · route	Labeler	Product NDC
Brimonidine Tartrate	Brimonidine tartrate 2 mg/mg	Solution/ dropsOphthalmic	Florida Pharmaceutical Products, LLC	71921-185