Metronidazole

Product NDC: 68071-1876
11-digit product format: 680711876
Labeler code: 68071
Product ID: 68071-1876_465660cf-2b4e-f757-e063-6294a90af71e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2014-06-01
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 28 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
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	68071-1876-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1876-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1876-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1876-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1876-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1876-8	`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	68071-1876-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1876-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1876-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1876-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1876-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1876-8	`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	68071-1876-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1876-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1876-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1876-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1876-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1876-8	`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	68071-1876-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1876-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1876-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1876-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1876-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1876-8	`1332a3947898…`	`d4bfe170f9cd…`

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
A203458-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2014-01-22
A203458-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2014-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203458-001	AB
A203458-002	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	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`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	A203458-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metronidazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
140QMO216E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	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
4040db14-750f-6d20-e054-00144ff8d46c	Available on FDA.report

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1876-1	2024-07-16	Metronidazole Tablets USP
68071-1876-2	2024-07-16	Metronidazole Tablets USP
68071-1876-3	2024-07-16	Metronidazole Tablets USP
68071-1876-4	2024-07-16	Metronidazole Tablets USP
68071-1876-5	2024-07-16	Metronidazole Tablets USP
68071-1876-8	2024-07-16	Metronidazole Tablets USP
68071-1876-1	2023-01-30	Metronidazole Tablets USP
68071-1876-2	2023-01-30	Metronidazole Tablets USP
68071-1876-3	2023-01-30	Metronidazole Tablets USP
68071-1876-4	2023-01-30	Metronidazole Tablets USP
68071-1876-5	2023-01-30	Metronidazole Tablets USP
68071-1876-8	2023-01-30	Metronidazole Tablets USP
68071-1876-1	2021-02-12	Metronidazole Tablets USP
68071-1876-2	2021-02-12	Metronidazole Tablets USP
68071-1876-3	2021-02-12	Metronidazole Tablets USP
68071-1876-4	2021-02-12	Metronidazole Tablets USP
68071-1876-5	2021-02-12	Metronidazole Tablets USP
68071-1876-8	2021-02-12	Metronidazole Tablets USP
68071-1876-1	2021-01-29	Metronidazole Tablets USP
68071-1876-2	2021-01-29	Metronidazole Tablets USP
68071-1876-3	2021-01-29	Metronidazole Tablets USP
68071-1876-4	2021-01-29	Metronidazole Tablets USP
68071-1876-5	2021-01-29	Metronidazole Tablets USP
68071-1876-8	2021-01-29	Metronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-1876-0	Metronidazole	42 in 1 BOTTLE	TABLET, FILM COATED	42	8
68071-1876-1	Metronidazole	4 in 1 BOTTLE	TABLET, FILM COATED	4	8
68071-1876-2	Metronidazole	21 in 1 BOTTLE	TABLET, FILM COATED	21	8
68071-1876-3	Metronidazole	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
68071-1876-4	Metronidazole	14 in 1 BOTTLE	TABLET, FILM COATED	14	8
68071-1876-5	Metronidazole	40 in 1 BOTTLE	TABLET, FILM COATED	40	8
68071-1876-8	Metronidazole	28 in 1 BOTTLE	TABLET, FILM COATED	28	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1876	METRONIDAZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 7 package rows	20250104_4040db14-750f-6d20-e054-00144ff8d46c.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	545f2900-745c-c33c-e063-6294a90a5e4f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	509c8d03-e199-8154-e063-6394a90afddc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	St. Mary's Medical Park Pharmacy	60689b96-cb58-925a-e053-2a91aa0a32a3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1277591d-ccf4-428a-b647-cb1ef3fbf561	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	BluePoint Laboratories	3cf021b6-5794-4a86-b09d-bece0ba8b302	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458 ndc (product): 68071-1876
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9a18debb-3bb8-4b23-949b-aaa0f3b62191	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458

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
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	4040db14-750f-6d20-e054-00144ff8d46c	8
311681	metronidazole 500 MG Oral Tablet	SCD	4040db14-750f-6d20-e054-00144ff8d46c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1876-0	68071187600	42 TABLET, FILM COATED in 1 BOTTLE (68071-1876-0)	2025-12-19		No	No	Current
68071-1876-1	68071187601	4 TABLET, FILM COATED in 1 BOTTLE (68071-1876-1)	2014-06-01	0000-00-00	No	No	Current
68071-1876-2	68071187602	21 TABLET, FILM COATED in 1 BOTTLE (68071-1876-2)	2014-06-01	0000-00-00	No	No	Current
68071-1876-3	68071187603	30 TABLET, FILM COATED in 1 BOTTLE (68071-1876-3)	2014-06-01	0000-00-00	No	No	Current
68071-1876-4	68071187604	14 TABLET, FILM COATED in 1 BOTTLE (68071-1876-4)	2014-06-01	0000-00-00	No	No	Current
68071-1876-5	68071187605	40 TABLET, FILM COATED in 1 BOTTLE (68071-1876-5)	2014-06-01	0000-00-00	No	No	Current
68071-1876-8	68071187608	28 TABLET, FILM COATED in 1 BOTTLE (68071-1876-8)	2014-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP	NuCare Pharmaceuticals, Inc.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	8