Metronidazole

Product NDC: 57664-653
11-digit product format: 576640653
Labeler code: 57664
Product ID: 57664-653_3130c0b1-b7d5-4d0b-8511-971de4a04687
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA070772
Marketing category: ANDA
Marketing start: 1986-07-16
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 250 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-653		D	Discontinued by firm	2026-08-03
excluded package	package	57664-653	57664-653-10	D	Discontinued by firm	2026-08-03
excluded package	package	57664-653	57664-653-88	D	Discontinued by firm	2026-08-03

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-653-88	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-653-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-653-88	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-653-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-653-88	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-653-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-653-88	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-653-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-653-88	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-653-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-653-88	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-653-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-653-88	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-653-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-653-88	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-653-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-653-88	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-653-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-653-88	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-653-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-653-88	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-653-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-653-88	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-653-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57664-653-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57664-653-88	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070772-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16
A070772-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16
A070772-003	METRONIDAZOLE	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A070772-001	AB
A070772-002	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 · 91 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	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`

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	A070772-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070772-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070772-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070772-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070772-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070772-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070772-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070772-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070772-002	AB	1	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Metronidazole	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
Metronidazole	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	METRONIDAZOLE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	99886f54-4ebe-4a2d-b779-bcfbb0634db1	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Method Pharmaceuticals LLC	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	9ed89bfc-ccf3-4e6c-924f-2a14bf82163f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
Metronidazole	METRONIDAZOLE	American Health Packaging	c90da73c-e48e-411a-bd75-0b107f1141cc	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ac7e80ce-6174-4246-a955-a92adc516571	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ceb47b-d0b0-d377-e053-2995a90a463e	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ce16b7-25c5-48aa-e053-2a95a90aa947	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	9f1fec88-097f-42b9-a36f-214648d7eebb	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	4920fcf7-5ceb-46e9-82e0-dc508900bb91	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METRONIDAZOLE TABLETS USP	Sun Pharmaceutical Industries, Inc.	2015-05-18	HUMAN PRESCRIPTION DRUG LABEL	1