METRONIDAZOLE

Product NDC: 47335-993
11-digit product format: 473350993
Labeler code: 47335
Product ID: 47335-993_9549fa19-5d89-4ad8-82ac-5d023072b126
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA212435
Marketing category: ANDA
Marketing start: 2021-08-10
Substance: METRONIDAZOLE
Active strength: 500 mg/100mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE / INJECTION	AP		2020-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212435-001	AP

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	2020-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212435-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212435-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212435-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212435-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212435-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212435-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212435-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212435-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212435-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212435-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212435-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212435-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212435-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212435-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212435-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212435-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212435-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212435-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212435-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212435-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212435-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212435-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212435-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212435-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212435-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212435-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212435-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212435-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212435-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212435-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212435-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212435-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212435-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212435-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212435-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212435-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212435-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212435-001	AP	1	`a50c72e98297…`

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/100mL

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
311683	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
7187779a-1f4c-4607-af53-4119e324aad5	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
47335-993-01	METRONIDAZOLE	1 in 1 POUCH	INJECTION, SOLUTION	1		4
47335-993-01	METRONIDAZOLE	100 mL in 1 BAG	INJECTION, SOLUTION	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-993-01	ML - Milliliter	47335-993	4dbfc914-bd05-48f2-bfa2-342d41b7e3f1	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-993	METRONIDAZOLE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240918_7187779a-1f4c-4607-af53-4119e324aad5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METRONIDAZOLE	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	7187779a-1f4c-4607-af53-4119e324aad5	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212435 application number: ANDA212435 ndc (product): 47335-993
Metronidazole	METRONIDAZOLE	Gland Pharma Limited	74cf111a-9b83-4f93-b0e8-bc252d471d43	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212435 application number: ANDA212435

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
311683	metroNIDAZOLE 500 MG in 100 ML Injection	PSN	7187779a-1f4c-4607-af53-4119e324aad5	4
311683	100 ML metronidazole 5 MG/ML Injection	SCD	7187779a-1f4c-4607-af53-4119e324aad5	4
311683	metronidazole 500 MG per 100 ML Injection	SY	7187779a-1f4c-4607-af53-4119e324aad5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-993-01	47335099301	1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG	1 bag	2021-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Injection USP 500 mg/100 mL (5 mg/mL) Sterile Rx Only For Intravenous Infusion Only	Sun Pharmaceutical Industries, Inc. \| Gland Pharma Limited	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	5