Home NDC 61748-011 Ethambutol Hydrochloride
Product NDC 61748-011
11-digit product format 617480011
Labeler code 61748
Product ID 61748-011_ec79c565-d8aa-4833-9e73-2dd058f96546
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethambutol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Versapharm Incorporated
Application ANDA075095
Marketing category ANDA
Marketing start 2015-03-18
Marketing end 0000-00-00
Substance ETHAMBUTOL HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61748-011-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61748-011-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61748-011-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61748-011-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61748-011-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61748-011-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61748-011-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61748-011-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61748-011-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61748-011-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61748-011-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61748-011-01 557ba5c1ecfa…9c80585c8c6e…
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 A075095-001 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 A075095-002 ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30
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 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075095-001 ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1999-11-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075095-002 ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB 1999-11-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHAMBUTOL HYDROCHLORIDE ACTIVE INGREDIENT QE4VW5FO07 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 ETHAMBUTOL ACTIVE MOIETY 8G167061QZ ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [VERSAPHARM INCORPORATED] 7
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61748-011-01 61748001101 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-011-01) 2015-03-18 0000-00-00 No No Current