NDC codes

FDA NDC Directory
Product NDC (as listed)42806-038Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0038Add 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
42806-038-014280600380142806003801100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01)Marketed from Jul 20, 2010
42806-038-1042806003810428060038101000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10)Marketed from Jul 20, 2010

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)
Betaxolol
Generic name (nonproprietary)
betaxolol
Active ingredients
Betaxolol hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Epic Pharma LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075541
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 42806-038_666cb1d9-ec1f-453a-be4f-fafa2b67c1fdSPL ID 666cb1d9-ec1f-453a-be4f-fafa2b67c1fdSPL set ID bf716efe-0a9f-43b1-9d8a-c69330b82e18RxCUI 1297753, 1297757UNII 6X97D2XT0O
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

N442806003801 followed by a unit qualifier and the quantity

Package 42806-0038-01. 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 Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-038

What is NDC 42806-038?
42806-038 is the product NDC for Betaxolol, Betaxolol hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Epic Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Betaxolol.
What is the active ingredient?
Betaxolol hydrochloride.
Who is the labeler?
Epic Pharma LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Betaxolol?
3 other product NDCs are listed under this name. See all Betaxolol 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 Betaxolol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BetaxololBetaxolol hydrochloride 10 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-70024658-0700-01
BetaxololBetaxolol hydrochloride 20 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-70124658-0701-01
BetaxololBetaxolol hydrochloride 20 mg/1Tablet, Film coatedOralEpic Pharma LLC42806-03942806-0039-0142806-0039-10

Other NDCs under ANDA 075541

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

FDA NDC Directory listings under ANDA 075541
ProductStrengthForm · routeLabelerProduct NDC
BetaxololBetaxolol hydrochloride 10 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-700
BetaxololBetaxolol hydrochloride 20 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-701
BetaxololBetaxolol hydrochloride 20 mg/1Tablet, Film coatedOralEpic Pharma LLC42806-039

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