Metronidazole

Product NDC: 67046-1173
Requested package NDC: 67046-1173-3
11-digit product format: 670461173
Labeler code: 67046
Product ID: 67046-1173_509c8d03-e16e-8154-e063-6394a90afddc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2026-04-29
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

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.

Product history page 1 of 2 · 58 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
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A203458-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A203458-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203458-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203458-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203458-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203458-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203458-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203458-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203458-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203458-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203458-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203458-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203458-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203458-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203458-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203458-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203458-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203458-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203458-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203458-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203458-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203458-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203458-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203458-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203458-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203458-002	AB	1	`9b2671bbb829…`

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 ndc (package): 67046-1173-3 ndc (product): 67046-1173 ndc11 (package): 67046117303
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: 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
509c8d03-e199-8154-e063-6394a90afddc	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
67046-1173-3	Metronidazole	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

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	509c8d03-e199-8154-e063-6394a90afddc	1
311681	metronidazole 500 MG Oral Tablet	SCD	509c8d03-e199-8154-e063-6394a90afddc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1173-3	67046117303	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1173-3)	2026-04-29	No	No	Current