NDC codes

FDA NDC Directory
Product NDC (as listed)64980-514Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0514Add 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
64980-514-0164980051401649800514011 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLEMarketed from Dec 15, 2014
64980-514-0564980051405649800514051 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLEMarketed from Dec 15, 2014
64980-514-1564980051415649800514151 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLEMarketed from Dec 15, 2014

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)
Timolol Maleate
Generic name (nonproprietary)
timolol maleate
Active ingredients
Timolol maleate — 5 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077259
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 64980-514_ce38c2fa-e404-40e3-b684-8c31a58245beSPL ID ce38c2fa-e404-40e3-b684-8c31a58245beSPL set ID 2ed21930-1e05-46de-8acd-cb6f4798a7faRxCUI 1923428, 1992303UNII P8Y54F701RUPC 0364980513050
Pharmacologic class
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

N464980051401 followed by a unit qualifier and the quantity

Package 64980-0514-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-514

What is NDC 64980-514?
64980-514 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Timolol Maleate.
What is the active ingredient?
Timolol maleate.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Timolol Maleate?
47 other product NDCs are listed under this name. See all Timolol Maleate 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 Timolol Maleate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Timolol MaleateTimolol maleate 2.5 mg/mLSolution, Gel forming / dropsOphthalmicSagent Pharmaceuticals25021-00825021-0008-05
Timolol MaleateTimolol maleate 5 mg/mLSolution, Gel forming / dropsOphthalmicSagent Pharmaceuticals25021-00925021-0009-05
Timolol MaleateTimolol maleate 5 mg/1TabletOralRising Pharma Holdings, Inc.16571-22316571-0223-01
Timolol MaleateTimolol maleate 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-22416571-0224-01
Timolol MaleateTimolol maleate 20 mg/1TabletOralRising Pharma Holdings, Inc.16571-22516571-0225-01
timolol maleateTimolol maleate 5 mg/mLSolution/ dropsOphthalmicNorthStar RxLLC72603-54072603-0540-01
Timolol MaleateTimolol maleate 5 mg/mLSolutionOphthalmicLeading Pharma, LLC69315-32569315-0325-0569315-0325-1069315-0325-15
Timolol MaleateTimolol maleate 2.5 mg/mLSolution, Gel forming / dropsOphthalmicSomerset Therapeutics, LLC70069-24170069-0241-01
Timolol MaleateTimolol maleate 5 mg/mLSolution, Gel forming / dropsOphthalmicSomerset Therapeutics, LLC70069-25170069-0251-01
Timolol MaleateTimolol maleate 5 mg/mLSolutionOphthalmicA-S Medication Solutions50090-783750090-7837-00

All 48 Timolol Maleate NDCs

Other NDCs under ANDA 077259

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

FDA NDC Directory listings under ANDA 077259
ProductStrengthForm · routeLabelerProduct NDC
Timolol MaleateTimolol maleate 5 mg/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-1852
Timolol MaleateTimolol maleate 2.5 mg/mLSolution/ dropsOphthalmicRising Pharma Holdings, Inc.64980-513

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in