Metronidazole

Product NDC: 64980-235
Requested package NDC: 64980-235-25
11-digit product format: 649800235
Labeler code: 64980
Product ID: 64980-235_0e31a067-d128-4d12-8e76-84cb2519ca3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA205245
Marketing category: ANDA
Marketing start: 2016-02-22
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 250 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64980-235	64980-235-25	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-235	64980-235-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-235	64980-235-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A205245-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-09-23
A205245-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205245-001	AB
A205245-002	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	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`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	A205245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-235-01	EA - Each	64980-235	2aa8546c-c04e-456f-9cc1-136af816d97a	1	2016-04-04
64980-235-05	EA - Each	64980-235	792dd9d5-1945-4a62-a91d-e3fdced37dbc	1	2016-04-04
64980-235-25	EA - Each	64980-235	6ec228cd-e4d5-4157-b618-f6bd34784804	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-235	METRONIDAZOLE TABLET [RISING PHARMACEUTICALS, INC.]	2	Legacy NDC	20171228_bf82510d-3327-429a-9da2-6ebd7d849e36.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	4e1ac737-c353-4764-bd35-dc844e75b562	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f2f55405-7f21-3ccc-e053-2a95a90a195a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f7e5dacd-0bc4-4ac4-e053-6394a90a457a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	40509b3c-b725-400c-abe5-d6d5714d405d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	71f5ce2f-17f8-45fc-b27d-2bf982591ab3	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	a860b097-7447-a3b7-e053-2995a90a4bfd	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d9e33638-3803-426e-a1c3-7d0cf145d92f	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ae2e4bbe-8c12-4af9-e053-2a95a90af299	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-235-25	64980023525	250 TABLET in 1 BOTTLE (64980-235-25)	250 tablet	2016-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METRONIDAZOLE Tablets, USP	Rising Pharmaceuticals, Inc. \| APPCO PHARMA LLC	2017-12-19	HUMAN PRESCRIPTION DRUG LABEL	2