Timolol Maleate NDC 0378-0221

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0221Add 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
0378-0221-01	00378022101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)Marketed from Jun 8, 1990

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072668
Marketing start: Jun 8, 1990
Marketing end: Mar 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 0378-0221_30d62085-4192-46af-b05a-da3eed7d1fc5SPL ID 30d62085-4192-46af-b05a-da3eed7d1fc5SPL set ID 57c62928-63d8-4505-9b9e-c085a3a12c95RxCUI 198284, 198285, 198286UNII P8Y54F701RUPC 0303780055018
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

N400378022101 followed by a unit qualifier and the quantity

Package 00378-0221-01. 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 Jul 6, 2020.

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)