Home NDC 66215-101 Tracleer
Product NDC 66215-101
11-digit product format 662150101
Labeler code 66215
Product ID 66215-101_f52a8c9c-529d-4bd8-9bfb-d91161935c20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bosentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA021290
Marketing category NDA
Marketing start 2001-11-20
Substance BOSENTAN
Active strength 62.5 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021290-001 TRACLEER BOSENTAN 62.5MG TABLET / ORAL AB RLD 2001-11-20 N021290-002 TRACLEER BOSENTAN 125MG TABLET / ORAL AB RLD, RS 2001-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tracleer
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSENTAN 62.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q326023R30 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349253 Internal RxNorm lookup 352066 Internal RxNorm lookup 656659 Internal RxNorm lookup 656660 Internal RxNorm lookup 1989081 Internal RxNorm lookup 1989085 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66215-101-03 Tracleer 10 in 1 CARTON TABLET, FILM COATED 10 36 66215-101-03 Tracleer 3 in 1 BLISTER PACK TABLET, FILM COATED 3 36 66215-101-06 Tracleer 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 36 66215-101-06 Tracleer 1 in 1 CARTON TABLET, FILM COATED 1 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bosentan ACTIVE INGREDIENT Q326023R30 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 bosentan anhydrous ACTIVE MOIETY XUL93R30K2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 glyceryl dibehenate INACTIVE INGREDIENT R8WTH25YS2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 povidone k90 INACTIVE INGREDIENT RDH86HJV5Z TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 starch, corn INACTIVE INGREDIENT O8232NY3SJ TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 talc INACTIVE INGREDIENT 7SEV7J4R1U TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10 triacetin INACTIVE INGREDIENT XHX3C3X673 TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-101 TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.] 32 Current NDC, Legacy NDC, 4 package rows 20240223_749e42fb-2fe0-45dd-9268-b43bb3f4081c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tracleer BOSENTAN Actelion Pharmaceuticals US, Inc. 749e42fb-2fe0-45dd-9268-b43bb3f4081c 2025-11-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021290 application number: NDA021290 ndc (product): 66215-101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66215-101-03 66215010103 10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2012-10-02 0000-00-00 No No Current 66215-101-06 66215010106 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2001-11-20 0000-00-00 No No Current