Home NDC 68180-281 Ethambutol Hydrochloride
Product NDC 68180-281
11-digit product format 681800281
Labeler code 68180
Product ID 68180-281_b76b5b09-9d5d-4343-b128-0266024919b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethambutol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA078939
Marketing category ANDA
Marketing start 2009-07-04
Substance ETHAMBUTOL HYDROCHLORIDE
Active strength 400 mg/1
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078939-001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 A078939-002 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078939-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2009-06-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078939-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 2009-06-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ethambutol Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHAMBUTOL HYDROCHLORIDE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QE4VW5FO07 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995599 Internal RxNorm lookup 995607 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 68180-281-01 Ethambutol Hydrochloride 100 in 1 BOTTLE TABLET 100 11 68180-281-02 Ethambutol Hydrochloride 500 in 1 BOTTLE TABLET 500 11 68180-281-11 Ethambutol Hydrochloride 14 in 1 BLISTER PACK TABLET 14 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-281 ETHAMBUTOL HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20250309_c732b415-e1f9-478f-896d-1dc8b6362da4.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 · 4 matching rows.
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 68180-281-01 68180028101 100 TABLET in 1 BOTTLE (68180-281-01) 100 tablet 2009-07-04 0000-00-00 No No Current 68180-281-02 68180028102 500 TABLET in 1 BOTTLE (68180-281-02) 500 tablet 2009-07-04 0000-00-00 No No Current 68180-281-11 68180028111 14 in 1 BLISTER PACK Historical 68180-281-13 68180028113 4 BLISTER PACK in 1 CARTON (68180-281-13) > 14 TABLET in 1 BLISTER PACK (68180-281-11) 4 blister pack 2009-07-04 0000-00-00 No No Current