Metronidazole

Product NDC: 70518-3265
Requested package NDC: 70518-3265-2
11-digit product format: 705183265
Labeler code: 70518
Product ID: 70518-3265_4edf38d6-4d30-183c-e063-6394a90a7f23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205245
Marketing category: ANDA
Marketing start: 2021-11-08
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metronidazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	500 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5cc3fd98-d579-432e-a4b5-b6d5586991a6	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
70518-3265-0	Metronidazole	14 in 1 BOTTLE, PLASTIC	TABLET	14	12
70518-3265-1	Metronidazole	4 in 1 BOTTLE, PLASTIC	TABLET	4	12
70518-3265-2	Metronidazole	14 in 1 BOTTLE, PLASTIC	TABLET	14	12
70518-3265-3	Metronidazole	4 in 1 BOTTLE, PLASTIC	TABLET	4	12
70518-3265-4	Metronidazole	20 in 1 BOTTLE, PLASTIC	TABLET	20	12
70518-3265-5	Metronidazole	30 in 1 BLISTER PACK	TABLET	30	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3265	METRONIDAZOLE TABLET [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 6 package rows	20241001_5cc3fd98-d579-432e-a4b5-b6d5586991a6.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 ndc (package): 70518-3265-2 ndc (product): 70518-3265 ndc11 (package): 70518326502
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	5cc3fd98-d579-432e-a4b5-b6d5586991a6	12
311681	metronidazole 500 MG Oral Tablet	SCD	5cc3fd98-d579-432e-a4b5-b6d5586991a6	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3265-2	70518326502	14 TABLET in 1 BOTTLE, PLASTIC (70518-3265-2)	14 tablet	2022-04-17	0000-00-00	No	No	Current