Metronidazole

Product NDC: 55154-2343
11-digit product format: 551542343
Labeler code: 55154
Product ID: 55154-2343_5e653564-7189-42a5-b0ec-a189e21d009b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA205245
Marketing category: ANDA
Marketing start: 2025-03-05
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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-09-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-09-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A205245-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205245-002	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	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 ndc (product): 55154-2343
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-04-07	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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4e1ac737-c353-4764-bd35-dc844e75b562	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
55154-2343-0	Metronidazole	1 in 1 BLISTER PACK	TABLET	1		2
55154-2343-0	Metronidazole	10 in 1 BAG	TABLET	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2343	METRONIDAZOLE TABLET [CARDINAL HEALTH 107, LLC]	1	Current NDC, 2 package rows	20250309_4e1ac737-c353-4764-bd35-dc844e75b562.zip

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	4e1ac737-c353-4764-bd35-dc844e75b562	2
314106	metronidazole 250 MG Oral Tablet	SCD	4e1ac737-c353-4764-bd35-dc844e75b562	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2343-0	55154234300	10 BLISTER PACK in 1 BAG (55154-2343-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2025-03-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	Cardinal Health 107, LLC	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	3