LIKMEZ

Product NDC: 81033-066
11-digit product format: 810330066
Labeler code: 81033
Product ID: 81033-066_2a82e6d7-cff9-deca-e063-6394a90a4817
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: NDA216755
Marketing category: NDA
Marketing start: 2023-10-13
Substance: METRONIDAZOLE
Active strength: 100 mg/mL
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
N216755-001	LIKMEZ	METRONIDAZOLE	500MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-09-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16
N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16
N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16
N216755-001	11541035	2039-10-04		Drug product	2023-10-18

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216755-001	LIKMEZ	500MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-09-22	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216755-001	12257236	2039-01-16	U-3169	Drug product	2025-04-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216755-001	12257236	2039-01-16	U-4163	Drug product	2025-04-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216755-001	12257236	2039-01-16	U-4164	Drug product	2025-04-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216755-001	11541035	2039-10-04		Drug product	2023-10-18	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: LIKMEZ
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	100 mg/mL

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
2667642	Internal RxNorm lookup
2667648	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
23927a8b-1641-4104-aa85-d7b7bf4ebb9d	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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
81033-066-20	LIKMEZ	200 mL in 1 BOTTLE	SUSPENSION	200		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-066	LIKMEZ (METRONIDAZOLE ORAL) SUSPENSION [KESIN PHARMA CORPORATION]	3	Current NDC, 1 package rows	20250101_23927a8b-1641-4104-aa85-d7b7bf4ebb9d.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
LIKMEZ	METRONIDAZOLE ORAL	Saptalis Pharmaceuticals, LLC	e20c14eb-5361-4a93-ab46-a7bd9aeb9b98	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216755 application number: NDA216755
LIKMEZ	METRONIDAZOLE ORAL	Kesin Pharma Corporation	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216755 application number: NDA216755 ndc (product): 81033-066

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
2667648	LIKMEZ 500 MG in 5 mL Oral Suspension	PSN	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667642	metroNIDAZOLE 500 MG in 5 mL Oral Suspension	PSN	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667648	metronidazole 100 MG/ML Oral Suspension [Likmez]	SBD	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667642	metronidazole 100 MG/ML Oral Suspension	SCD	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667648	Likmez 100 MG/ML Oral Suspension	SY	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667648	Likmez 500 MG per 5 ML Oral Suspension	SY	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3
2667642	metronidazole 500 MG per 5 ML Oral Suspension	SY	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-066-20	81033006620	200 mL in 1 BOTTLE (81033-066-20)	200 ml	2023-10-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIKMEZ	Kesin Pharma Corporation \| Saptalis Pharmaceuticals, LLC	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	3