Labetalol Hydrochloride NDC 0904-7451

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7451Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7451Add 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
0904-7451-61	00904745161	100 BLISTER PACK in 1 CARTON (0904-7451-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 8, 2024

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): Labetalol Hydrochloride
Generic name (nonproprietary): labetalol hydrochloride
Active ingredients: Labetalol hydrochloride — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209603
Marketing start: Oct 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 0904-7451_25dba2c0-ab5f-48c1-8768-533d26a16b53SPL ID 25dba2c0-ab5f-48c1-8768-533d26a16b53SPL set ID 35b5fd32-581d-427b-9a13-b7a02846d21dRxCUI 896758, 896762, 896766UNII 1GEV3BAW9J
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

N400904745161 followed by a unit qualifier and the quantity

Package 00904-7451-61. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.