metronidazole

Product NDC: 50090-5307
11-digit product format: 500905307
Labeler code: 50090
Product ID: 50090-5307_b325c79e-1c4b-4928-a7d2-247ae8765dc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA206560
Marketing category: ANDA
Marketing start: 2019-02-23
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 250 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-5307		I	Inactivated by FDA	2026-08-17
excluded package	package	50090-5307	50090-5307-0	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-5307	50090-5307-1	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-5307	50090-5307-2	I	Inactivated by FDA	2026-08-17

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 · 60 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	50090-5307-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5307-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5307-2	`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	50090-5307-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5307-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5307-2	`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	50090-5307-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5307-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5307-2	`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	50090-5307-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5307-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5307-2	`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	50090-5307-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5307-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5307-2	`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	50090-5307-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5307-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5307-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5307-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5307-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5307-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5307-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5307-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5307-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5307-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5307-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5307-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5307-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5307-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5307-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5307-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5307-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5307-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5307-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5307-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5307-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-5307-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-5307-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-5307-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-5307-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-5307-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-5307-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-5307-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-5307-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-5307-2	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206560-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2016-11-16
A206560-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2016-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206560-001	AB
A206560-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-11-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206560-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206560-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206560-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206560-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206560-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206560-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206560-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206560-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206560-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206560-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206560-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206560-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206560-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206560-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206560-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206560-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206560-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206560-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206560-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206560-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206560-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206560-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206560-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206560-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206560-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206560-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206560-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206560-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206560-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206560-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206560-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206560-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206560-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5307-0	2023-01-30	C162847	48780-1	f386c649-f196-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
50090-5307-1	2023-01-30	C162847	48780-1	f386c649-f196-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
50090-5307-2	2023-01-30	C162847	48780-1	f386c649-f196-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5307-0	metronidazole	21 in 1 BOTTLE	TABLET	21	3
50090-5307-1	metronidazole	28 in 1 BOTTLE	TABLET	28	3
50090-5307-2	metronidazole	30 in 1 BOTTLE	TABLET	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5307	METRONIDAZOLE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 3 package rows	20210417_45d77dc9-e050-4d6f-80e0-6dbc5e0b41aa.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	b49a8ad0-2cf9-4386-8bf5-1b1df87b0022	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	d5784eeb-6b99-4e8a-847b-b0d1090ed48a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	e3a32908-9db1-6ca7-e053-2a95a90a82fb	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Sportpharm LLC	dc8e448e-ac4e-4efc-8851-c368e31b9d69	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	ab695a3e-1721-491a-97a2-c3f617a8d9fc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	06bd4afb-4a45-294c-e063-6394a90a7ab1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	8f1de4ca-a005-4ca9-a43a-380429c80d6f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	356579f3-a9ed-49cf-bc0d-47b58a58cf85	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	0f108035-d2ab-49c1-9f8d-daae11f0efe0	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
METRONIDAZOLE	METRONIDAZOLE	Zydus Lifesciences Limited	f3ef765c-b531-4aaa-a86d-e32b7254ca48	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	9e702861-87f5-4bc0-864d-317050020194	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1030e723-cde9-44a7-8dab-2f0932ffcc2c	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Asclemed USA, Inc.	89970965-a995-4ae4-a70b-bd2de38081e1	2024-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2024-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	45d77dc9-e050-4d6f-80e0-6dbc5e0b41aa	3
314106	metronidazole 250 MG Oral Tablet	SCD	45d77dc9-e050-4d6f-80e0-6dbc5e0b41aa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5307-0	50090530700	21 TABLET in 1 BOTTLE (50090-5307-0)	21 tablet	2020-10-28	0000-00-00	No	No	Current
50090-5307-1	50090530701	28 TABLET in 1 BOTTLE (50090-5307-1)	28 tablet	2020-10-28	0000-00-00	No	No	Current
50090-5307-2	50090530702	30 TABLET in 1 BOTTLE (50090-5307-2)	30 tablet	2020-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3