Metronidazole

Product NDC: 46708-021
11-digit product format: 467080021
Labeler code: 46708
Product ID: 46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA090222
Marketing category: ANDA
Marketing start: 2010-05-07
Substance: METRONIDAZOLE
Active strength: 750 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090222-001	METRONIDAZOLE	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL			2010-05-05

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090222-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-05-05	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	750 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
636559	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
80c79325-1ea4-46f8-b9b8-967b7640c51d	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
46708-021-30	2023-02-01	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-31	2023-02-01	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-50	2023-02-01	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-71	2023-02-01	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-30	2023-01-30	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-31	2023-01-30	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-50	2023-01-30	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-021-71	2023-01-30	Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-021-30	Metronidazole	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	13
46708-021-31	Metronidazole	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	13
46708-021-50	Metronidazole	50 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	50	13
46708-021-71	Metronidazole	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-021	METRONIDAZOLE TABLET, FILM COATED, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	13	Current NDC, Legacy NDC, 4 package rows	20230202_80c79325-1ea4-46f8-b9b8-967b7640c51d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	80c79325-1ea4-46f8-b9b8-967b7640c51d	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090222 application number: ANDA090222 ndc (product): 46708-021

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
636559	metroNIDAZOLE 750 MG 24HR Extended Release Oral Tablet	PSN	80c79325-1ea4-46f8-b9b8-967b7640c51d	13
636559	24 HR metronidazole 750 MG Extended Release Oral Tablet	SCD	80c79325-1ea4-46f8-b9b8-967b7640c51d	13
636559	metronidazole 750 MG 24 HR Extended Release Oral Tablet	SY	80c79325-1ea4-46f8-b9b8-967b7640c51d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-021-30	46708002130	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30)	2010-05-07	0000-00-00	No	No	Current
46708-021-31	46708002131	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31)	2010-05-07	0000-00-00	No	No	Current
46708-021-50	46708002150	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50)	2010-05-07	0000-00-00	No	No	Current
46708-021-71	46708002171	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71)	2010-05-07	0000-00-00	No	No	Current