NDC codes

FDA NDC Directory
Product NDC (as listed)71921-188Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71921-0188Add 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 NDC11-digit (billing)PackageCopy
71921-188-05719210188051 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 23, 2023
71921-188-10719210188101 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Nov 23, 2023
71921-188-15719210188151 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Nov 23, 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 And Timolol Maleate
Generic name (nonproprietary)
brimonidine tartrate and timolol maleate
Active ingredients
Brimonidine tartrate — 2 mg/mLTimolol maleate — 5 mg/mL
Dosage form
Solution
Route
Ophthalmic
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201949
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 71921-188_41d7b9be-f2ee-4cb5-ae7e-dcb281591b53SPL ID 41d7b9be-f2ee-4cb5-ae7e-dcb281591b53SPL set ID 7011a203-46cf-434d-ba11-253f107ff80fRxCUI 861635UNII 4S9CL2DY2H, P8Y54F701RUPC 0371921188055
Pharmacologic class
alpha-Adrenergic Agonist; beta-Adrenergic Blocker

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

N471921018805 followed by a unit qualifier and the quantity

Package 71921-0188-05. 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 .

Indications (excerpt from the label)

Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine tartrate/timolol maleate combination of brimonidine tartrate, an alpha-adrenergic receptor agonist, and timolol malea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201949

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

FDA NDC Directory listings under ANDA 201949
ProductStrengthForm · routeLabelerProduct NDC
Brimonidine tartrate and Timolol maleateBrimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mLSolution/ dropsOphthalmicNorthStar RxLLC72603-931
Brimonidine Tartrate/Timolol Maleatebrimonidine tartrate and timolol maleateBrimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mLSolution/ dropsOphthalmicARMAS PHARMACEUTICALS INC72485-634

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