NDC 68180-340Prescription (Rx only)FDA ANDA · ANDA213154

Bosentan

Active substance: Bosentan

FDA labeler: Lupin Pharmaceuticals, Inc.

11 formulations • 37 package configurations

All 48 registered NDCs — click to copy

In one line

Bosentan (Bosentan) NDC 68180-340 converts to 68180-0340-13 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence

Listing: 68180-340 Verified

1. Initial Approval

2025

First U.S. FDA clearance for Bosentan

2. FDA Application

ANDA213154

Regulatory pathway: ANDA

3. Market Entry Date

Aug 18, 2025

First commercial NDC distribution & launch date

4. Regulatory Status

Active Commercial Listing

Registration valid through Dec 31, 2026

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

68180-0340-13

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.

Every registered strength and package for Bosentan, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
32 mg/1	68180-340-13	68180-340	68180-0340-13	4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK
62.5 mg/1	70771-1017-1	70771-1017	70771-1017-01	100 TABLET in 1 BOTTLE (70771-1017-1)
62.5 mg/1	70771-1017-4	70771-1017	70771-1017-04	10 BLISTER PACK in 1 CARTON (70771-1017-4) / 10 TABLET in 1 BLISTER PACK (70771-1017-2)
Inner component	70771-1017-2	70771-1017	70771-1017-02	Inner component of kit (70771-1017-4)
62.5 mg/1	70771-1017-5	70771-1017	70771-1017-05	500 TABLET in 1 BOTTLE (70771-1017-5)
62.5 mg/1	70771-1017-6	70771-1017	70771-1017-06	60 TABLET in 1 BOTTLE (70771-1017-6)
62.5 mg/1	70771-1017-8	70771-1017	70771-1017-08	180 TABLET in 1 BOTTLE (70771-1017-8)
125 mg/1	70771-1018-1	70771-1018	70771-1018-01	100 TABLET in 1 BOTTLE (70771-1018-1)
125 mg/1	70771-1018-4	70771-1018	70771-1018-04	10 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2)
Inner component	70771-1018-2	70771-1018	70771-1018-02	Inner component of kit (70771-1018-4)
125 mg/1	70771-1018-5	70771-1018	70771-1018-05	500 TABLET in 1 BOTTLE (70771-1018-5)
125 mg/1	70771-1018-6	70771-1018	70771-1018-06	60 TABLET in 1 BOTTLE (70771-1018-6)
125 mg/1	70771-1018-8	70771-1018	70771-1018-08	180 TABLET in 1 BOTTLE (70771-1018-8)
32 mg/1	70771-1908-8	70771-1908	70771-1908-08	4 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7)
Inner component	70771-1908-7	70771-1908	70771-1908-07	Inner component of kit (70771-1908-8)
62.5 mg/1	68382-446-01	68382-446	68382-0446-01	100 TABLET, COATED in 1 BOTTLE (68382-446-01)
62.5 mg/1	68382-446-05	68382-446	68382-0446-05	500 TABLET, COATED in 1 BOTTLE (68382-446-05)
62.5 mg/1	68382-446-14	68382-446	68382-0446-14	60 TABLET, COATED in 1 BOTTLE (68382-446-14)
62.5 mg/1	68382-446-28	68382-446	68382-0446-28	180 TABLET, COATED in 1 BOTTLE (68382-446-28)
62.5 mg/1	68382-446-77	68382-446	68382-0446-77	10 BLISTER PACK in 1 CARTON (68382-446-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-446-30)
Inner component	68382-446-30	68382-446	68382-0446-30	Inner component of kit (68382-446-77)
125 mg/1	68382-447-01	68382-447	68382-0447-01	100 TABLET, COATED in 1 BOTTLE (68382-447-01)
125 mg/1	68382-447-05	68382-447	68382-0447-05	500 TABLET, COATED in 1 BOTTLE (68382-447-05)
125 mg/1	68382-447-14	68382-447	68382-0447-14	60 TABLET, COATED in 1 BOTTLE (68382-447-14)
125 mg/1	68382-447-28	68382-447	68382-0447-28	180 TABLET, COATED in 1 BOTTLE (68382-447-28)
125 mg/1	68382-447-77	68382-447	68382-0447-77	10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)
Inner component	68382-447-30	68382-447	68382-0447-30	Inner component of kit (68382-447-77)
62.5 mg/1	0591-2511-60	0591-2511	00591-2511-60	60 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)
125 mg/1	0591-2512-60	0591-2512	00591-2512-60	60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60)
62.5 mg/1	47335-038-64	47335-038	47335-0038-64	10 BLISTER PACK in 1 CARTON (47335-038-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-038-60)
Inner component	47335-038-60	47335-038	47335-0038-60	Inner component of kit (47335-038-64)
62.5 mg/1	47335-038-86	47335-038	47335-0038-86	60 TABLET, FILM COATED in 1 BOTTLE (47335-038-86)
125 mg/1	47335-039-64	47335-039	47335-0039-64	10 BLISTER PACK in 1 CARTON (47335-039-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60)
Inner component	47335-039-60	47335-039	47335-0039-60	Inner component of kit (47335-039-64)
125 mg/1	47335-039-86	47335-039	47335-0039-86	60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86)
32 mg/1	70710-1508-8	70710-1508	70710-1508-08	4 BLISTER PACK in 1 CARTON (70710-1508-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70710-1508-7)
Inner component	70710-1508-7	70710-1508	70710-1508-07	Inner component of kit (70710-1508-8)

No Structured Product Labeling submission was returned for this listing, so the sections below are derived from its FDA registration record rather than the manufacturer's label.

6 Label Sections

INDICATIONS AND USAGE

Bosentan is indicated for clinical therapeutic management as active pharmaceutical therapy containing BOSENTAN (32 mg/1).

DOSAGE AND ADMINISTRATION

Dosage must be individualized based on clinical therapeutic goals, route of administration (ORAL), and patient response. Refer to licensed physician prescribing guidelines.

DOSAGE FORMS AND STRENGTHS

Supplied as TABLET, FOR SUSPENSION. Active ingredients: BOSENTAN (32 mg/1).

CONTRAINDICATIONS

Contraindicated in patients with severe hypersensitivity to Bosentan or formulation components.

WARNINGS AND PRECAUTIONS

Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.

HOW SUPPLIED / STORAGE AND HANDLING

Supplied under FDA Labeler: Lupin Pharmaceuticals, Inc.. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.

Pharmacologic class

Cytochrome P450 2C9 Inducers

Every other National Drug Code registered in the same established class.

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FDA Approval & Market Entry Timeline

NDC • HCPCS Level II • CPT administration

All registered strengths & packaging

Prescribing information

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Cytochrome P450 2C9 Inducers