metronidazole

Product NDC: 58657-933
Requested package NDC: 58657-933-01
11-digit product format: 586570933
Labeler code: 58657
Product ID: 58657-933_51018185-a67f-bf2c-e063-6394a90adca5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Method Pharmaceuticals LLC
Application: ANDA070772
Marketing category: ANDA
Marketing start: 2025-07-01
Substance: METRONIDAZOLE
Active strength: 250 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070772-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16
A070772-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16
A070772-003	METRONIDAZOLE	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070772-001	AB
A070772-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A070772-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070772-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070772-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070772-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070772-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070772-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070772-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070772-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070772-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A070772-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070772-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A070772-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070772-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070772-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070772-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070772-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070772-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070772-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070772-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070772-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070772-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A070772-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070772-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A070772-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070772-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070772-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070772-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A070772-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070772-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A070772-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070772-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070772-002	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A070772-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070772-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Bryant Ranch Prepack	99886f54-4ebe-4a2d-b779-bcfbb0634db1	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Method Pharmaceuticals LLC	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (package): 58657-933-01 ndc (product): 58657-933 ndc11 (package): 58657093301
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	9ed89bfc-ccf3-4e6c-924f-2a14bf82163f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
Metronidazole	METRONIDAZOLE	American Health Packaging	c90da73c-e48e-411a-bd75-0b107f1141cc	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ac7e80ce-6174-4246-a955-a92adc516571	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ceb47b-d0b0-d377-e053-2995a90a463e	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ce16b7-25c5-48aa-e053-2a95a90aa947	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	9f1fec88-097f-42b9-a36f-214648d7eebb	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	4920fcf7-5ceb-46e9-82e0-dc508900bb91	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	Internal RxNorm lookup
314106	Internal RxNorm lookup
2702348	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
2ae49bf4-a23b-bdcc-e063-6294a90a80a9	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
58657-933-01	metronidazole	100 in 1 CARTON	TABLET	100	4
58657-933-05	metronidazole	50 in 1 CARTON	TABLET	50	4
58657-933-10	metronidazole	1 in 1 BLISTER PACK	TABLET	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-933-01	EA - Each	58657-933	60d8f68e-a724-455a-8a9b-ceab85c40af7	1	2025-10-14
58657-933-05	EA - Each	58657-933	efe83a53-b13a-4f59-a906-a5ca74c9e3cf	1	2025-10-14

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
2702348	metroNIDAZOLE 125 MG Oral Tablet	PSN	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4
2702348	metronidazole 125 MG Oral Tablet	SCD	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4
314106	metronidazole 250 MG Oral Tablet	SCD	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4
311681	metronidazole 500 MG Oral Tablet	SCD	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58657-933-01	58657093301	100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10)	100 blister pack	2025-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	Method Pharmaceuticals LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	4