Metronidazole

Product NDC: 46708-428
Requested package NDC: 46708-428-50
11-digit product format: 467080428
Labeler code: 46708
Product ID: 46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA079067
Marketing category: ANDA
Marketing start: 2016-12-01
Substance: METRONIDAZOLE
Active strength: 250 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 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
A079067-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2009-03-13
A079067-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2009-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079067-001	AB
A079067-002	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	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`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	A079067-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079067-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079067-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079067-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079067-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079067-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079067-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079067-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079067-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079067-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079067-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079067-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079067-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079067-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079067-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079067-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079067-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079067-002	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	250 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	Internal RxNorm lookup
314106	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
d7455566-16aa-488a-af2a-93b55a04c02f	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
46708-428-30	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-31	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-50	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-61	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-71	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-91	2023-02-01	METRONIDAZOLE - metronidazole tablet
46708-428-30	2023-01-30	METRONIDAZOLE - metronidazole tablet
46708-428-31	2023-01-30	METRONIDAZOLE - metronidazole tablet
46708-428-50	2023-01-30	METRONIDAZOLE - metronidazole tablet
46708-428-61	2023-01-30	METRONIDAZOLE - metronidazole tablet
46708-428-71	2023-01-30	METRONIDAZOLE - metronidazole tablet
46708-428-91	2023-01-30	METRONIDAZOLE - metronidazole tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-428-30	Metronidazole	30 in 1 BOTTLE	TABLET	30	3
46708-428-31	Metronidazole	100 in 1 BOTTLE	TABLET	100	3
46708-428-50	Metronidazole	50 in 1 BOTTLE	TABLET	50	3
46708-428-61	Metronidazole	250 in 1 BOTTLE	TABLET	250	3
46708-428-71	Metronidazole	500 in 1 BOTTLE	TABLET	500	3
46708-428-91	Metronidazole	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-428	METRONIDAZOLE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 6 package rows	20230202_d7455566-16aa-488a-af2a-93b55a04c02f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	aea4e2a1-2089-40dc-9eee-deaab4f21397	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	b85bdc1f-1ffb-40d5-a407-e8de2891996d	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	8522493d-0a18-49dd-8d49-bd159f6ee332	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	b2bd62c2-c6ed-f459-e053-2a95a90a90eb	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	b1fcf023-cdfd-45b7-b4d4-ff814f33ee79	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	937913b8-c131-6339-e053-2a95a90a4dd9	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	d7455566-16aa-488a-af2a-93b55a04c02f	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (package): 46708-428-50 ndc (product): 46708-428 ndc11 (package): 46708042850
Metronidazole	METRONIDAZOLE	AvPAK	9623181f-5e3b-3695-e053-2a95a90a99f6	2022-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067

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	d7455566-16aa-488a-af2a-93b55a04c02f	3
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	d7455566-16aa-488a-af2a-93b55a04c02f	3
314106	metronidazole 250 MG Oral Tablet	SCD	d7455566-16aa-488a-af2a-93b55a04c02f	3
311681	metronidazole 500 MG Oral Tablet	SCD	d7455566-16aa-488a-af2a-93b55a04c02f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-428-50	46708042850	50 TABLET in 1 BOTTLE (46708-428-50)	50 tablet	2016-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METRONIDAZOLE - metronidazole tablet	Alembic Pharmaceuticals Limited	2023-01-30	Human Prescription Drug Label	3