Ethambutol Hydrochloride

Product NDC: 70518-2966
11-digit product format: 705182966
Labeler code: 70518
Product ID: 70518-2966_4aba550b-837b-4af9-e063-6394a90af074
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethambutol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078939
Marketing category: ANDA
Marketing start: 2020-12-11
Substance: ETHAMBUTOL HYDROCHLORIDE
Active strength: 400 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2966	70518-2966-1	D	Discontinued by firm		2026-08-11

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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.

Application-product, TE code table
Application-product	TE code
A078939-001	AB
A078939-002	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078939-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078939-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078939-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078939-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078939-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078939-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078939-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078939-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078939-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078939-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078939-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078939-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078939-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078939-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078939-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078939-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ethambutol Hydrochloride
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c12b3482-55f0-4324-bdcd-b129ca2dae73	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e86e15b7-896a-6fb4-16e3-cf6efd994b64	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-10	ETHAMBUTOL HYDROCHLORIDE TABLETS USP
2022-02-10	ETHAMBUTOL HYDROCHLORIDE TABLETS USP
2022-02-10	ETHAMBUTOL HYDROCHLORIDE TABLETS USP
2022-01-28	ETHAMBUTOL HYDROCHLORIDE TABLETS USP
2022-01-28	ETHAMBUTOL HYDROCHLORIDE TABLETS USP
2022-01-28	ETHAMBUTOL HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-2966-0	Ethambutol Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	12
70518-2966-1	Ethambutol Hydrochloride	100 in 1 BOX	TABLET	100	12
70518-2966-2	Ethambutol Hydrochloride	1 in 1 POUCH	TABLET	1	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2966	ETHAMBUTOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 3 package rows	20250409_c12b3482-55f0-4324-bdcd-b129ca2dae73.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	REMEDYREPACK INC.	c12b3482-55f0-4324-bdcd-b129ca2dae73	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939 ndc (product): 70518-2966
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	REMEDYREPACK INC.	e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	c732b415-e1f9-478f-896d-1dc8b6362da4	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	American Health Packaging	d32e9865-8edd-4644-9939-62ed119db3ef	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QE4VW5FO07	ETHAMBUTOL HYDROCHLORIDE	1070-11-7	ETHAMBUTOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995607	ethambutol HCl 400 MG Oral Tablet	PSN	c12b3482-55f0-4324-bdcd-b129ca2dae73	12
995607	ethambutol hydrochloride 400 MG Oral Tablet	SCD	c12b3482-55f0-4324-bdcd-b129ca2dae73	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2966-0	70518296600	30 TABLET in 1 BLISTER PACK (70518-2966-0)	30 tablet	2020-12-11	0000-00-00	No	No	Current
70518-2966-1	70518296601	100 in 1 BOX						Historical
70518-2966-2	70518296602	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETHAMBUTOL HYDROCHLORIDE TABLETS USP	REMEDYREPACK INC.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	13