METRONIDAZOLE

Product NDC: 61919-032
Requested package NDC: 61919-032-14
11-digit product format: 619190032
Labeler code: 61919
Product ID: 61919-032_47e13e06-0078-1557-e063-6294a90a5f79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2019-08-21
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-032	61919-032-14	I	Inactivated by FDA		2026-07-31

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 ndc (product): 61919-032
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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	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
90a5acb3-f8cc-1e82-e053-2995a90a4e97	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-032-04	2026-01-29	C162847	48780-1	9d75b9d0-ae40-f424-e053-dadaa90a57ce	METRONIDAZOLE 500mg
61919-032-14	2026-01-29	C162847	48780-1	9d75b9d0-ae40-f424-e053-dadaa90a57ce	METRONIDAZOLE 500mg
61919-032-30	2022-08-09	C162847	48780-1	ba0f9c33-2803-a910-e053-dadaa90a0b85	METRONIDAZOLE 500mg
61919-032-21	2021-01-29	C162847	48780-1	ba0f9c33-1dff-a910-e053-dadaa90a0b85	METRONIDAZOLE
61919-032-30	2021-01-29	C162847	48780-1	ba0f9c33-2803-a910-e053-dadaa90a0b85	METRONIDAZOLE 500mg
61919-032-14	2020-12-14	C162847	48780-1	9d75b9d0-ae40-f424-e053-dadaa90a57ce	METRONIDAZOLE 500mg
61919-032-14	2020-01-31	C162847	48780-1	9d75b9d0-ae40-f424-e053-dadaa90a57ce	METRONIDAZOLE 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-032-04	METRONIDAZOLE	4 in 1 BOTTLE	TABLET, FILM COATED	4	10
61919-032-14	METRONIDAZOLE	14 in 1 BOTTLE	TABLET, FILM COATED	14	10
61919-032-10	METRONIDAZOLE	10 in 1 BOTTLE	TABLET, FILM COATED	10	6
61919-032-30	METRONIDAZOLE	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
61919-032-21	METRONIDAZOLE	21 in 1 BOTTLE	TABLET, FILM COATED	21	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-032-04	EA - Each	61919-032	f7e5562b-94db-41dc-aeb8-2089932b0846	1	2022-03-09
61919-032-10	EA - Each	61919-032	72f192bf-0584-46f2-a866-3d9155c6f177	1	2019-09-05
61919-032-14	EA - Each	61919-032	dba6604d-76ea-448c-ae5f-417cf7584123	1	2017-04-05
61919-032-21	EA - Each	61919-032	c3295f21-366b-4bfc-a44e-23c6bd8cfab4	1	2019-09-05
61919-032-30	EA - Each	61919-032	e5c42bfa-e53d-43d4-96ee-df51ca7b85f5	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-032	METRONIDAZOLE TABLET, FILM COATED [DIRECT RX]	10	Current NDC, Legacy NDC, 2 package rows	20240110_48836437-c2c2-1ea2-e054-00144ff8d46c.zip
61919-032	METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]	5	Current NDC, Legacy NDC, 1 package rows	20240110_90a5acb3-f8cc-1e82-e053-2995a90a4e97.zip
61919-032	METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]	3	Current NDC, Legacy NDC, 1 package rows	20240110_90a6139b-66e8-7754-e053-2a95a90af815.zip
61919-032	METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20220919_90a56d96-a454-3fb3-e053-2a95a90ad291.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
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	48836437-c2c2-1ea2-e054-00144ff8d46c	10
311681	metronidazole 500 MG Oral Tablet	SCD	48836437-c2c2-1ea2-e054-00144ff8d46c	10
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a5acb3-f8cc-1e82-e053-2995a90a4e97	6
311681	metronidazole 500 MG Oral Tablet	SCD	90a5acb3-f8cc-1e82-e053-2995a90a4e97	6
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a6139b-66e8-7754-e053-2a95a90af815	3
311681	metronidazole 500 MG Oral Tablet	SCD	90a6139b-66e8-7754-e053-2a95a90af815	3
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a56d96-a454-3fb3-e053-2a95a90ad291	2
311681	metronidazole 500 MG Oral Tablet	SCD	90a56d96-a454-3fb3-e053-2a95a90ad291	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-032-14	61919003214	14 TABLET, FILM COATED in 1 BOTTLE (61919-032-14)	2017-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METRONIDAZOLE 500mg	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	6
METRONIDAZOLE 500mg	DIRECT RX	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	10
METRONIDAZOLE 500mg	Direct_Rx	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
METRONIDAZOLE	Direct_Rx	2022-08-02	HUMAN PRESCRIPTION DRUG LABEL	2