metronidazole

Product NDC: 69292-207
11-digit product format: 692920207
Labeler code: 69292
Product ID: 69292-207_ea93595d-72b5-4df4-8251-3e66be6db5d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: AMICI PHARMA INC
Application: ANDA070772
Marketing category: ANDA
Marketing start: 2019-08-26
Substance: METRONIDAZOLE
Active strength: 250 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 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.

Product history page 1 of 3 · 91 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	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`

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	A070772-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070772-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070772-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070772-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070772-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070772-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070772-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070772-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070772-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: metronidazole
Listing expiration: 2026-12-31

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 · 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
4920fcf7-5ceb-46e9-82e0-dc508900bb91	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
69292-207-01	metronidazole	100 in 1 BOTTLE	TABLET	100		15
69292-207-50	metronidazole	500 in 1 BOTTLE	TABLET	500		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69292-207-50	EA - Each	69292-207	800eef5a-0a92-4787-9bbe-5cc1fb693537	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69292-207	METRONIDAZOLE TABLET [AMICI PHARMA INC]	15	Current NDC, Legacy NDC, 2 package rows	20250413_4920fcf7-5ceb-46e9-82e0-dc508900bb91.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	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
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 ndc (product): 69292-207

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
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	4920fcf7-5ceb-46e9-82e0-dc508900bb91	15
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	4920fcf7-5ceb-46e9-82e0-dc508900bb91	15
314106	metronidazole 250 MG Oral Tablet	SCD	4920fcf7-5ceb-46e9-82e0-dc508900bb91	15
311681	metronidazole 500 MG Oral Tablet	SCD	4920fcf7-5ceb-46e9-82e0-dc508900bb91	15
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	a6ceb47b-d0b0-d377-e053-2995a90a463e	8
314106	metronidazole 250 MG Oral Tablet	SCD	a6ceb47b-d0b0-d377-e053-2995a90a463e	8
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	c90da73c-e48e-411a-bd75-0b107f1141cc	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	c90da73c-e48e-411a-bd75-0b107f1141cc	7
314106	metronidazole 250 MG Oral Tablet	SCD	c90da73c-e48e-411a-bd75-0b107f1141cc	7
311681	metronidazole 500 MG Oral Tablet	SCD	c90da73c-e48e-411a-bd75-0b107f1141cc	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69292-207-01	69292020701	100 TABLET in 1 BOTTLE (69292-207-01)	100 tablet	2019-08-26	0000-00-00	No	No	Current
69292-207-50	69292020750	500 TABLET in 1 BOTTLE (69292-207-50)	500 tablet	2019-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP 8442401/0825 Rx only	American Health Packaging	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	7
Metronidazole Tablets, USP Rx only	Golden State Medical Supply, Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	8
Metronidazole Tablets, USP Rx only	AMICI PHARMA INC \| Frontida Biopharm, Inc. \| Innogenix, LLC	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	15