metronidazole

Product NDC: 72789-195
11-digit product format: 727890195
Labeler code: 72789
Product ID: 72789-195_40abd4b1-5378-c5b0-e063-6394a90af09d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA206560
Marketing category: ANDA
Marketing start: 2019-02-23
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 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…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8f1de4ca-a005-4ca9-a43a-380429c80d6f	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72789-195-06	metronidazole	6 in 1 BOTTLE, PLASTIC	TABLET	6	13
72789-195-21	metronidazole	21 in 1 BOTTLE, PLASTIC	TABLET	21	13
72789-195-30	metronidazole	30 in 1 BOTTLE, PLASTIC	TABLET	30	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-195-06	EA - Each	72789-195	33e667c3-6f53-45b3-a9e8-aa4aa32bf30e	1	2022-01-06
72789-195-21	EA - Each	72789-195	a54c4624-d105-420a-8c42-20d28bd77a3c	1	2022-01-06
72789-195-30	EA - Each	72789-195	0581fd11-e381-4a82-a92e-7b2735b10e29	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-195	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 3 package rows	20240906_8f1de4ca-a005-4ca9-a43a-380429c80d6f.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 · 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 ndc (product): 72789-195
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	8f1de4ca-a005-4ca9-a43a-380429c80d6f	13
314106	metronidazole 250 MG Oral Tablet	SCD	8f1de4ca-a005-4ca9-a43a-380429c80d6f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-195-06	72789019506	6 TABLET in 1 BOTTLE, PLASTIC (72789-195-06)	6 tablet	2021-10-29	0000-00-00	No	No	Current
72789-195-21	72789019521	21 TABLET in 1 BOTTLE, PLASTIC (72789-195-21)	21 tablet	2021-06-30	0000-00-00	No	No	Current
72789-195-30	72789019530	30 TABLET in 1 BOTTLE, PLASTIC (72789-195-30)	30 tablet	2021-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	13