Metronidazole

Product NDC: 71335-1609
11-digit product format: 713351609
Labeler code: 71335
Product ID: 71335-1609_5b997b5e-c9e3-4e84-98e2-60b36d5fc11c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205245
Marketing category: ANDA
Marketing start: 2017-11-29
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1609		D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-0	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-1	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-2	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-3	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-4	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-5	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-6	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-7	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-8	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1609	71335-1609-9	D	Discontinued by firm	2026-08-10

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 3 · 132 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	71335-1609-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1609-7	`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	71335-1609-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1609-7	`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	71335-1609-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1609-7	`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	71335-1609-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1609-7	`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	71335-1609-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1609-7	`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	71335-1609-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1609-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1609-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1609-1	`cdf11ea48f46…`	`ba0047e9e063…`

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
A205245-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-09-23
A205245-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205245-001	AB
A205245-002	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	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`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	A205245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	AB	1	`782e0a99824c…`

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	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	4e1ac737-c353-4764-bd35-dc844e75b562	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f2f55405-7f21-3ccc-e053-2a95a90a195a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f7e5dacd-0bc4-4ac4-e053-6394a90a457a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	40509b3c-b725-400c-abe5-d6d5714d405d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	71f5ce2f-17f8-45fc-b27d-2bf982591ab3	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	a860b097-7447-a3b7-e053-2995a90a4bfd	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d9e33638-3803-426e-a1c3-7d0cf145d92f	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ae2e4bbe-8c12-4af9-e053-2a95a90af299	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1609-0	71335160900	40 TABLET in 1 BOTTLE (71335-1609-0)	40 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-1	71335160901	20 TABLET in 1 BOTTLE (71335-1609-1)	20 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-2	71335160902	30 TABLET in 1 BOTTLE (71335-1609-2)	30 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-3	71335160903	14 TABLET in 1 BOTTLE (71335-1609-3)	14 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-4	71335160904	56 TABLET in 1 BOTTLE (71335-1609-4)	56 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-5	71335160905	21 TABLET in 1 BOTTLE (71335-1609-5)	21 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-6	71335160906	4 TABLET in 1 BOTTLE (71335-1609-6)	4 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-7	71335160907	28 TABLET in 1 BOTTLE (71335-1609-7)	28 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-8	71335160908	100 TABLET in 1 BOTTLE (71335-1609-8)	100 tablet	2020-06-04	0000-00-00	No	No	Current
71335-1609-9	71335160909	60 TABLET in 1 BOTTLE (71335-1609-9)	60 tablet	2020-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	2