Metronidazole

Product NDC: 62332-018
11-digit product format: 623320018
Labeler code: 62332
Product ID: 62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA079065
Marketing category: ANDA
Marketing start: 2016-12-09
Substance: METRONIDAZOLE
Active strength: 375 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
A079065-001	METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB		2009-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079065-001	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 2 · 42 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	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079065-001	METRONIDAZOLE	375MG	CAPSULE / ORAL	AB	2009-06-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A079065-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079065-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079065-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079065-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079065-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079065-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079065-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079065-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079065-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079065-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079065-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079065-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079065-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079065-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079065-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079065-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079065-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079065-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079065-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079065-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079065-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079065-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079065-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079065-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079065-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079065-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079065-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079065-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079065-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079065-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079065-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079065-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079065-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079065-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079065-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079065-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079065-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079065-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079065-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079065-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	375 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
199055	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
f9b4c86c-932b-4b43-ab1a-6d9e07958044	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62332-018-30	Metronidazole	30 in 1 BOTTLE	CAPSULE	30	13
62332-018-31	Metronidazole	100 in 1 BOTTLE	CAPSULE	100	13
62332-018-50	Metronidazole	50 in 1 BOTTLE	CAPSULE	50	13
62332-018-71	Metronidazole	500 in 1 BOTTLE	CAPSULE	500	13
62332-018-91	Metronidazole	1000 in 1 BOTTLE	CAPSULE	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-018-50	EA - Each	62332-018	03febebc-7537-4edf-97a1-fccbc9cfde79	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-018	METRONIDAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]	13	Current NDC, Legacy NDC, 5 package rows	20250302_f9b4c86c-932b-4b43-ab1a-6d9e07958044.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	f9b4c86c-932b-4b43-ab1a-6d9e07958044	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079065 application number: ANDA079065 ndc (product): 62332-018
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	387053e5-7eda-4282-b58a-5789430a2e99	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079065 application number: ANDA079065

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
199055	metroNIDAZOLE 375 MG Oral Capsule	PSN	f9b4c86c-932b-4b43-ab1a-6d9e07958044	13
199055	metronidazole 375 MG Oral Capsule	SCD	f9b4c86c-932b-4b43-ab1a-6d9e07958044	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-018-30	62332001830	30 CAPSULE in 1 BOTTLE (62332-018-30)	30 capsule	2016-12-09	0000-00-00	No	No	Current
62332-018-31	62332001831	100 CAPSULE in 1 BOTTLE (62332-018-31)	100 capsule	2016-12-09	0000-00-00	No	No	Current
62332-018-50	62332001850	50 CAPSULE in 1 BOTTLE (62332-018-50)	50 capsule	2016-12-09	0000-00-00	No	No	Current
62332-018-71	62332001871	500 CAPSULE in 1 BOTTLE (62332-018-71)	500 capsule	2016-12-09	0000-00-00	No	No	Current
62332-018-91	62332001891	1000 CAPSULE in 1 BOTTLE (62332-018-91)	1000 capsule	2016-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Capsules USP 375 mg	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2025-02-26	Human Prescription Drug Label	13