Home NDC 10135-797 ETHAMBUTOL HYDROCHLORIDE
Product NDC 10135-797
11-digit product format 101350797
Labeler code 10135
Product ID 10135-797_2dcb6b41-b9a8-4dde-8248-334d13f87a29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETHAMBUTOL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application NDA016320
Marketing category NDA
Marketing start 2006-12-15
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016320-001 MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 100MG TABLET / ORAL AB RLD, Approved before 1982 N016320-002 MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 200MG TABLET / ORAL Approved before 1982 N016320-003 MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 N016320-004 MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 500MG TABLET / ORAL Approved before 1982
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 5 · 164 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 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N016320-001 MYAMBUTOL 100MG TABLET / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016320-002 MYAMBUTOL 200MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016320-003 MYAMBUTOL 400MG TABLET / ORAL AB RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016320-004 MYAMBUTOL 500MG TABLET / ORAL Approved before 1982 d06236e962d9…
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 10135-797-01 ETHAMBUTOL HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 1
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 10135-797-01 10135079701 100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01) 2025-08-26 No No Current