Metronidazole

Product NDC: 29300-226
11-digit product format: 293000226
Labeler code: 29300
Product ID: 29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2014-06-01
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
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.

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	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2014-01-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2014-01-22	`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	A203458-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203458-002	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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2025-12-19	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

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
9219588b-0a99-40b9-bdd4-ced6d6efebed	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
29300-226-01	Metronidazole	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16
29300-226-05	Metronidazole	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	16
29300-226-10	Metronidazole	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	16
29300-226-46	Metronidazole	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	16
29300-226-52	Metronidazole	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-226-01	EA - Each	29300-226	9288afa8-a84a-4476-8b62-773f90b332ab	1	2014-09-03
29300-226-05	EA - Each	29300-226	b17f0ea8-376d-44ee-9caf-afc7982908e6	1	2014-09-03
29300-226-52	EA - Each	29300-226	7a941620-3386-41e3-b959-b515bb374ccc	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-226	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	16	Current NDC, Legacy NDC, 5 package rows	20240806_9219588b-0a99-40b9-bdd4-ced6d6efebed.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	8e1f507b-22fa-4033-9b3e-5435f20ace66	103
314106	metronidazole 250 MG Oral Tablet	SCD	8e1f507b-22fa-4033-9b3e-5435f20ace66	103
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	23
314106	metronidazole 250 MG Oral Tablet	SCD	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	23
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	22
314106	metronidazole 250 MG Oral Tablet	SCD	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	22
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	cfeab9e3-58b9-4890-9185-11b62904e2af	20
314106	metronidazole 250 MG Oral Tablet	SCD	cfeab9e3-58b9-4890-9185-11b62904e2af	20
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
314106	metronidazole 250 MG Oral Tablet	SCD	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
311681	metronidazole 500 MG Oral Tablet	SCD	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	3e0a14f1-961b-4722-bfea-aafcc5d7706c	8
314106	metronidazole 250 MG Oral Tablet	SCD	3e0a14f1-961b-4722-bfea-aafcc5d7706c	8
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	4ab90d8e-c21f-65ac-e054-00144ff8d46c	5
314106	metronidazole 250 MG Oral Tablet	SCD	4ab90d8e-c21f-65ac-e054-00144ff8d46c	5
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	9141e5b4-f5fc-bc71-e053-2a95a90aa138	3
314106	metronidazole 250 MG Oral Tablet	SCD	9141e5b4-f5fc-bc71-e053-2a95a90aa138	3
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	6851b2c8-86d0-21c3-e053-2a91aa0ae64d	2
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	6a77b5b6-3199-4526-bd68-2e511353d7c6	2
314106	metronidazole 250 MG Oral Tablet	SCD	6851b2c8-86d0-21c3-e053-2a91aa0ae64d	2
314106	metronidazole 250 MG Oral Tablet	SCD	6a77b5b6-3199-4526-bd68-2e511353d7c6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-226-01	29300022601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-01)	2014-06-01	0000-00-00	No	No	Current
29300-226-05	29300022605	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-05)	2014-06-01	0000-00-00	No	No	Current
29300-226-10	29300022610	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-10)	2014-06-01	0000-00-00	No	No	Current
29300-226-46	29300022646	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-46)	2014-06-01	0000-00-00	No	No	Current
29300-226-52	29300022652	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-52)	2014-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP	REMEDYREPACK INC.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	21
Metronidazole Tablets USP	Preferred Pharmaceuticals Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	9
Metronidazole Tablets USP	A-S Medication Solutions	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	23
Metronidazole Tablets USP	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	22
Metronidazole Tablets USP	NuCare Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
Metronidazole Tablets USP	Bryant Ranch Prepack	2024-09-04	HUMAN PRESCRIPTION DRUG LABEL	103
Metronidazole Tablets USP	Unichem Pharmaceuticals (USA), Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	16
Metronidazole Tablets USP	REMEDYREPACK INC.	2023-02-20	HUMAN PRESCRIPTION DRUG LABEL	9
METRONIDAZOLE	DIRECT RX	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP	PharmPak, Inc.	2022-10-09	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-25	HUMAN PRESCRIPTION DRUG LABEL	2
METRONIDAZOLE	Direct_Rx	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL	3
Metronidazole Tablets USP	NuCare Pharmaceuticals, Inc.	2019-03-11	HUMAN PRESCRIPTION DRUG LABEL	3