Metronidazole

Product NDC: 67046-1060
11-digit product format: 670461060
Labeler code: 67046
Product ID: 67046-1060_545f1c56-176e-68bd-e063-6394a90a77bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2026-06-16
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203458-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2014-01-22
A203458-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2014-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203458-001	AB
A203458-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203458-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203458-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203458-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203458-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203458-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	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
545f2900-745c-c33c-e063-6294a90a5e4f	Available on FDA.report

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	545f2900-745c-c33c-e063-6294a90a5e4f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458 ndc (product): 67046-1060
Metronidazole	METRONIDAZOLE	Coupler LLC	509c8d03-e199-8154-e063-6394a90afddc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	St. Mary's Medical Park Pharmacy	60689b96-cb58-925a-e053-2a91aa0a32a3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1277591d-ccf4-428a-b647-cb1ef3fbf561	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	BluePoint Laboratories	3cf021b6-5794-4a86-b09d-bece0ba8b302	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9a18debb-3bb8-4b23-949b-aaa0f3b62191	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458

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	Marketing start	Sample	Exclude flag	Status
67046-1060-3	67046106003	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1060-3)	2026-06-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP	Coupler LLC \| Unichem Pharmaceuticals (USA), Inc.	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	1