Metronidazole

Product NDC: 50111-334
11-digit product format: 501110334
Labeler code: 50111
Product ID: 50111-334_c6f82723-a668-4dc1-96ea-816620a5b964
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA070033
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: METRONIDAZOLE
Active strength: 500 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
A070033-001	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		1984-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070033-001	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	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`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	A070033-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070033-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	Internal RxNorm lookup
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
291a45f6-ed27-4dcc-8364-358d08623797	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	Strength	SPL version
50111-334-01	Metronidazole	100 in 1 BOTTLE	TABLET	100		18
50111-334-02	Metronidazole	500 in 1 BOTTLE	TABLET	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-334-01	EA - Each	50111-334	87298088-a4ea-4b2c-af48-a1ccb59046fe	1	2012-07-24
50111-334-02	EA - Each	50111-334	7314927f-64e9-47be-8999-f744f289aadd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [PLIVA INC.]	5
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [PLIVA INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [PLIVA INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [PLIVA INC.]	5
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [PLIVA INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [PLIVA INC.]	5
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]	4
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [PROFICIENT RX LP]	3
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [PROFICIENT RX LP]	3
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [PROFICIENT RX LP]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]	3
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]	2
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [KAISER FOUNDATION HOSPITALS]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [APACE PACKAGING]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [KAISER FOUNDATION HOSPITALS]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [APACE PACKAGING]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [APACE PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [KAISER FOUNDATION HOSPITALS]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [KAISER FOUNDATION HOSPITALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [APACE PACKAGING]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [KAISER FOUNDATION HOSPITALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [APACE PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METRONIDAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50111-334	METRONIDAZOLE TABLET [TEVA PHARMACEUTICALS USA, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20240724_291a45f6-ed27-4dcc-8364-358d08623797.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	53918705-d2fe-4c6b-9501-a619a8ad3991	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	1a28dce0-07af-401a-a6ac-1c2ee559c668	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Redpharm Drug, inc.	f426cddc-8b70-c0a7-e053-2995a90a74e0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	e1e7e127-e99e-80e9-1606-71261658b0c1	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Proficient Rx LP	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 50111-334

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	e1e7e127-e99e-80e9-1606-71261658b0c1	29
311681	metronidazole 500 MG Oral Tablet	SCD	e1e7e127-e99e-80e9-1606-71261658b0c1	29
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	53918705-d2fe-4c6b-9501-a619a8ad3991	19
311681	metronidazole 500 MG Oral Tablet	SCD	53918705-d2fe-4c6b-9501-a619a8ad3991	19
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	291a45f6-ed27-4dcc-8364-358d08623797	18
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	291a45f6-ed27-4dcc-8364-358d08623797	18
314106	metronidazole 250 MG Oral Tablet	SCD	291a45f6-ed27-4dcc-8364-358d08623797	18
311681	metronidazole 500 MG Oral Tablet	SCD	291a45f6-ed27-4dcc-8364-358d08623797	18
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	1a28dce0-07af-401a-a6ac-1c2ee559c668	13
311681	metronidazole 500 MG Oral Tablet	SCD	1a28dce0-07af-401a-a6ac-1c2ee559c668	13
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	9
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	c7bc09dc-32a5-4163-a30e-1b598119ee97	9
311681	metronidazole 500 MG Oral Tablet	SCD	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	9
311681	metronidazole 500 MG Oral Tablet	SCD	c7bc09dc-32a5-4163-a30e-1b598119ee97	9
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	a59fd68d-a8ab-4004-b73c-0e9d6e887efd	5
311681	metronidazole 500 MG Oral Tablet	SCD	a59fd68d-a8ab-4004-b73c-0e9d6e887efd	5
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	a775da83-6554-4229-afb8-92cdcfb4503e	4
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	a775da83-6554-4229-afb8-92cdcfb4503e	4
314106	metronidazole 250 MG Oral Tablet	SCD	a775da83-6554-4229-afb8-92cdcfb4503e	4
311681	metronidazole 500 MG Oral Tablet	SCD	a775da83-6554-4229-afb8-92cdcfb4503e	4
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	f426cddc-8b70-c0a7-e053-2995a90a74e0	3
311681	metronidazole 500 MG Oral Tablet	SCD	f426cddc-8b70-c0a7-e053-2995a90a74e0	3
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	3193a61d-acc4-445a-8bb9-328568d43937	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	96230db1-1c79-72e3-e053-2995a90ad73f	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	6d969bc3-8182-4b4b-862e-3fb6a5cfc04f	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	3193a61d-acc4-445a-8bb9-328568d43937	2
314106	metronidazole 250 MG Oral Tablet	SCD	3193a61d-acc4-445a-8bb9-328568d43937	2
311681	metronidazole 500 MG Oral Tablet	SCD	96230db1-1c79-72e3-e053-2995a90ad73f	2
311681	metronidazole 500 MG Oral Tablet	SCD	6d969bc3-8182-4b4b-862e-3fb6a5cfc04f	2
311681	metronidazole 500 MG Oral Tablet	SCD	3193a61d-acc4-445a-8bb9-328568d43937	2
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	5911e8f2-1b3a-4222-b997-d2a1c9a9f535	1
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	d552db0a-959c-4ad9-ab65-d7cc541baf7e	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	d552db0a-959c-4ad9-ab65-d7cc541baf7e	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	f0a90f3c-a6c2-4e84-af9d-6f0470bce59b	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	e186510b-9fa5-4325-b4ed-90aa0c5e181f	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	5911e8f2-1b3a-4222-b997-d2a1c9a9f535	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	600d4d38-40d8-4b2c-9386-873f663fdd19	1
314106	metronidazole 250 MG Oral Tablet	SCD	d552db0a-959c-4ad9-ab65-d7cc541baf7e	1
314106	metronidazole 250 MG Oral Tablet	SCD	5911e8f2-1b3a-4222-b997-d2a1c9a9f535	1
311681	metronidazole 500 MG Oral Tablet	SCD	e186510b-9fa5-4325-b4ed-90aa0c5e181f	1
311681	metronidazole 500 MG Oral Tablet	SCD	d552db0a-959c-4ad9-ab65-d7cc541baf7e	1
311681	metronidazole 500 MG Oral Tablet	SCD	600d4d38-40d8-4b2c-9386-873f663fdd19	1
311681	metronidazole 500 MG Oral Tablet	SCD	5911e8f2-1b3a-4222-b997-d2a1c9a9f535	1
311681	metronidazole 500 MG Oral Tablet	SCD	f0a90f3c-a6c2-4e84-af9d-6f0470bce59b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50111-334-01	50111033401	100 TABLET in 1 BOTTLE (50111-334-01)	100 tablet	1990-09-30	0000-00-00	No	No	Current
50111-334-02	50111033402	500 TABLET in 1 BOTTLE (50111-334-02)	500 tablet	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP	REMEDYREPACK INC.	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	20
Metronidazole Tablets, USP	REMEDYREPACK INC.	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	13
Metronidazole Tablets, USP	Redpharm Drug, inc.	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	3
Metronidazole Tablets, USP	Bryant Ranch Prepack	2024-11-04	HUMAN PRESCRIPTION DRUG LABEL	29
METRONIDAZOLE TABLETS USP	Proficient Rx LP	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	9
Metronidazole Tablets, USP	Teva Pharmaceuticals USA, Inc.	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	18
Metronidazole Tablets, USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Metronidazole Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	14
Metronidazole Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2022-03-14	HUMAN PRESCRIPTION DRUG LABEL	13
Metronidazole Tablets USP	A-S Medication Solutions	2021-02-26	HUMAN PRESCRIPTION DRUG LABEL	9
Metronidazole Tablets USP	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP	Bryant Ranch Prepack	2020-10-12	HUMAN PRESCRIPTION DRUG LABEL	7
METRONIDAZOLE TABLETS USP	KAISER FOUNDATION HOSPITALS	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	2
METRONIDAZOLE TABLETS USP	St Marys Medical Park Pharmacy \| Teva Czech Industries s.r.o	2018-11-15	HUMAN PRESCRIPTION DRUG LABEL	4
METRONIDAZOLE TABLETS USP	QPharma Inc \| Teva Pharmaceuticals USA, Inc. \| Denton Pharma, Inc.	2018-05-24	HUMAN PRESCRIPTION DRUG LABEL	1
METRONIDAZOLE TABLETS USP	A-S Medication Solutions	2018-03-14	HUMAN PRESCRIPTION DRUG LABEL	3
METRONIDAZOLE TABLETS USP	A-S Medication Solutions	2018-02-13	HUMAN PRESCRIPTION DRUG LABEL	5
METRONIDAZOLE TABLETS USP	Central Texas Community Health Centers	2016-11-09	HUMAN PRESCRIPTION DRUG LABEL	1
METRONIDAZOLE TABLETS USP	Blenheim Pharmacal, Inc.	2015-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole	Northwind Pharmaceuticals, LLC	2014-09-23	HUMAN PRESCRIPTION DRUG LABEL	1