Ethambutol Hydrochloride

Product NDC: 70518-3662
Requested package NDC: 70518-3662-1
11-digit product format: 705183662
Labeler code: 70518
Product ID: 70518-3662_5905d3ca-1eac-bdff-e063-6394a90a51e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethambutol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078939
Marketing category: ANDA
Marketing start: 2023-02-26
Substance: ETHAMBUTOL HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078939-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078939-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078939-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078939-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	100 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
995599	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
e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3662-0	Ethambutol Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	5
70518-3662-1	Ethambutol Hydrochloride	50 in 1 BOX	TABLET	50	5
70518-3662-2	Ethambutol Hydrochloride	1 in 1 POUCH	TABLET	1	5

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.	e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939 ndc (package): 70518-3662-1 ndc (product): 70518-3662 ndc11 (package): 70518366201
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
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
995599	ethambutol HCl 100 MG Oral Tablet	PSN	e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	5
995599	ethambutol hydrochloride 100 MG Oral Tablet	SCD	e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3662-1	70518366201	50 POUCH in 1 BOX (70518-3662-1) / 1 TABLET in 1 POUCH (70518-3662-2)	50 pouch	2026-04-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETHAMBUTOL HYDROCHLORIDE TABLETS USP	REMEDYREPACK INC.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	6