What is NDC 42571-398?

42571-398 is the product NDC for Timolol Maleate, Timolol maleate 6.8 mg/mL solution/ drops, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Timolol Maleate NDC 42571-398 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-398Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0398Add 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
42571-398-71	4257103987142571039871	6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIALMarketed 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): Timolol Maleate
Generic name (nonproprietary): timolol maleate
Active ingredients: Timolol maleate — 6.8 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216596
Marketing start: Jan 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 42571-398_2882b434-4502-6a6e-e063-6394a90af575SPL ID 2882b434-4502-6a6e-e063-6394a90af575SPL set ID 79b223e4-d929-4667-8149-e79bfab13fdfRxCUI 1922894UNII P8Y54F701R
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

N442571039871 followed by a unit qualifier and the quantity

Package 42571-0398-71. 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 5, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42571-398

What is NDC 42571-398?: 42571-398 is the product NDC for Timolol Maleate, Timolol maleate 6.8 mg/mL solution/ drops, listed with the FDA by Micro Labs Limited. It has 1 package NDC, 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?: Micro Labs Limited, NDC labeler code 42571. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Timolol Maleate	Timolol maleate 2.5 mg/mL	Solution, Gel forming / dropsOphthalmic	Sagent Pharmaceuticals	25021-008	25021-0008-05
Timolol Maleate	Timolol maleate 5 mg/mL	Solution, Gel forming / dropsOphthalmic	Sagent Pharmaceuticals	25021-009	25021-0009-05
Timolol Maleate	Timolol maleate 5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-223	16571-0223-01
Timolol Maleate	Timolol maleate 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-224	16571-0224-01
Timolol Maleate	Timolol maleate 20 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-225	16571-0225-01
timolol maleate	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	NorthStar RxLLC	72603-540	72603-0540-01
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-325	69315-0325-0569315-0325-1069315-0325-15
Timolol Maleate	Timolol maleate 2.5 mg/mL	Solution, Gel forming / dropsOphthalmic	Somerset Therapeutics, LLC	70069-241	70069-0241-01
Timolol Maleate	Timolol maleate 5 mg/mL	Solution, Gel forming / dropsOphthalmic	Somerset Therapeutics, LLC	70069-251	70069-0251-01
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	A-S Medication Solutions	50090-7837	50090-7837-00

All 48 Timolol Maleate NDCs