metronidazole

Product NDC: 68788-7955
11-digit product format: 687887955
Labeler code: 68788
Product ID: 68788-7955_e2d06906-721a-4299-aff5-03e80ca4127a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc
Application: ANDA206560
Marketing category: ANDA
Marketing start: 2021-07-08
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7955		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7955	68788-7955-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7955	68788-7955-2	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7955	68788-7955-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7955	68788-7955-4	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7955	68788-7955-6	D	Discontinued by firm	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 2 · 72 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	68788-7955-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7955-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7955-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7955-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7955-1	`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	68788-7955-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7955-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7955-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7955-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7955-1	`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	68788-7955-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7955-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7955-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7955-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7955-1	`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	68788-7955-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7955-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7955-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7955-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7955-1	`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	68788-7955-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7955-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7955-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7955-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7955-1	`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	68788-7955-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7955-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7955-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7955-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7955-1	`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	68788-7955-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7955-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7955-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7955-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7955-1	`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	68788-7955-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7955-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7955-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7955-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7955-1	`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	68788-7955-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7955-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7955-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7955-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7955-1	`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	68788-7955-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7955-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7955-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7955-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7955-1	`ad56d346431e…`	`cc804d4bbf1e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7955-1	EA - Each	68788-7955	d646ec7b-59b8-4f71-9bb7-001a2b70b5f8	1	2021-08-05
68788-7955-2	EA - Each	68788-7955	75d1fd0f-8618-4187-bb09-718168b891a4	1	2021-08-05
68788-7955-3	EA - Each	68788-7955	b5824841-c05a-458c-a460-cbd2a14065f3	1	2021-08-05
68788-7955-4	EA - Each	68788-7955	da912e04-1a4c-42cf-9e67-ab562ff717f9	1	2021-08-05
68788-7955-6	EA - Each	68788-7955	9a5a53b2-5f6d-49d4-a54b-79046c76c1a5	1	2021-08-05

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7955-1	68788795501	14 TABLET in 1 BOTTLE (68788-7955-1)	14 tablet	2021-07-08	0000-00-00	No	No	Current
68788-7955-2	68788795502	21 TABLET in 1 BOTTLE (68788-7955-2)	21 tablet	2021-07-08	0000-00-00	No	No	Current
68788-7955-3	68788795503	30 TABLET in 1 BOTTLE (68788-7955-3)	30 tablet	2021-07-08	0000-00-00	No	No	Current
68788-7955-4	68788795504	28 TABLET in 1 BOTTLE (68788-7955-4)	28 tablet	2021-07-08	0000-00-00	No	No	Current
68788-7955-6	68788795506	60 TABLET in 1 BOTTLE (68788-7955-6)	60 tablet	2021-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	Preferred Pharmaceuticals Inc	2022-09-12	HUMAN PRESCRIPTION DRUG LABEL	2