Home NDC 68084-280 Ethambutol Hydrochloride
Product NDC 68084-280
11-digit product format 680840280
Labeler code 68084
Product ID 68084-280_3f1882fc-606c-8c87-e063-6294a90aa227
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethambutol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA078939
Marketing category ANDA
Marketing start 2009-12-16
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68084-280-01 Ethambutol Hydrochloride 100 in 1 BOX, UNIT-DOSE TABLET 100 7 68084-280-11 Ethambutol Hydrochloride 1 in 1 BLISTER PACK TABLET 1 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-280 ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 6 Current NDC, Legacy NDC, 2 package rows 20240806_d32e9865-8edd-4644-9939-62ed119db3ef.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 68084-280-01 68084028001 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) / 1 TABLET in 1 BLISTER PACK (68084-280-11) 100 blister pack 2009-12-16 0000-00-00 No No Current 68084-280-11 68084028011 1 in 1 BLISTER PACK Historical