Timolol Maleate NDC 16571-224

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-224Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0224Add 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
16571-224-01	16571022401	100 TABLET in 1 BOTTLE (16571-224-01)Marketed from Dec 10, 2024

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207556
Marketing start: Dec 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 16571-224_ebb620d8-8e2e-4632-b8a8-74f41c9969e6SPL ID ebb620d8-8e2e-4632-b8a8-74f41c9969e6SPL set ID 0bc40b2c-65eb-4095-87e6-4752d5b19a3aRxCUI 198284, 198285, 198286UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416571022401 followed by a unit qualifier and the quantity

Package 16571-0224-01. 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 Jun 11, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hypertension Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Myocardial Infarction Timolol is indicated in patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction. Migraine Timolol is indicated for the prophylaxis of migraine headache.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207556

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

FDA NDC Directory listings under ANDA 207556
Product	Strength	Form · route	Labeler	Product NDC
Timolol Maleate	Timolol maleate 5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-223
Timolol Maleate	Timolol maleate 20 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-225