Home NDC 70710-1166-5 MACITENTAN
Product NDC 70710-1166
Requested package NDC 70710-1166-5
11-digit product format 707101166
Labeler code 70710
Product ID 70710-1166_a5723ac2-5bfa-4270-9268-6a6533a841f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MACITENTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA211224
Marketing category ANDA
Marketing start 2025-11-05
Substance MACITENTAN
Active strength 10 mg/1
Pharmacologic classes Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70710-1166 70710-1166-5 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211224-001 MACITENTAN MACITENTAN 10MG TABLET / ORAL AB 2021-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211224-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211224-001 PC 2026-12-03
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.
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 2026-02-19 14:30 UTC 2026-02 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211224-001 MACITENTAN 10MG TABLET / ORAL AB 2021-04-06 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211224-001 MACITENTAN 10MG TABLET / ORAL 2021-04-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211224-001 MACITENTAN 10MG TABLET / ORAL AB 2021-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211224-001 AB 1 87673890dc5c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211224-001 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211224-001 PC 2026-12-03 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base MACITENTAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MACITENTAN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z9K9Y9WMVL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1442137 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 70710-1166-3 MACITENTAN 30 in 1 BOTTLE TABLET, FILM COATED 30 6 70710-1166-4 MACITENTAN 3 in 1 BLISTER PACK TABLET, FILM COATED 3 6 70710-1166-5 MACITENTAN 5 in 1 CARTON TABLET, FILM COATED 5 6
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-1166-5 70710116605 5 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4) 5 blister pack 2025-11-05 No No Current