METRONIDAZOLE

Product NDC: 66993-960
11-digit product format: 669930960
Labeler code: 66993
Product ID: 66993-960_47d8cbcd-bd51-4931-a912-949721c2749d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: CREAM
Route: TOPICAL
Labeler: Prasco Laboratories
Application: NDA020531
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-06-18
Marketing end: 2027-05-31
Substance: METRONIDAZOLE
Active strength: 7.5 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020531-001	METROCREAM	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020531-001	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 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020531-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020531-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020531-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020531-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020531-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020531-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020531-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020531-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020531-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020531-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020531-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020531-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020531-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020531-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020531-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020531-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020531-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020531-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020531-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020531-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020531-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020531-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020531-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020531-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020531-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020531-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020531-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020531-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020531-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020531-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020531-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020531-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020531-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020531-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020531-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020531-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020531-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020531-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020531-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020531-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: METRONIDAZOLE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	7.5 mg/g

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
311678	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
a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66993-960-45	METRONIDAZOLE	45 g in 1 TUBE	CREAM	45		5
66993-960-45	METRONIDAZOLE	1 in 1 CARTON	CREAM	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-960-45	GM - Gram	66993-960	02272dcb-682f-48b5-91a0-6fbb75b0f016	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-960	METRONIDAZOLE CREAM [PRASCO LABORATORIES]	5	Current NDC, Legacy NDC, 2 package rows	20241116_a6ce81f5-a5c6-44d7-b5f0-61d0530345bd.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	Prasco Laboratories	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	2024-11-07	Adverse reactions	Exact identifier application applno (NDA): 020531 application number: NDA020531 ndc (product): 66993-960
METRONIDAZOLE	METRONIDAZOLE	Mayne Pharma Inc.	567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9	2024-10-31	Adverse reactions	Exact identifier application applno (NDA): 020531 application number: NDA020531

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
311678	metroNIDAZOLE 0.75 % Topical Cream	PSN	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	5
311678	metronidazole 7.5 MG/ML Topical Cream	SCD	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	5
311678	metronidazole 0.75 % Topical Cream	SY	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	5
311678	metroNIDAZOLE 0.75 % Topical Cream	PSN	d39922f0-c37c-fec3-e053-2995a90a141c	2
311678	metronidazole 7.5 MG/ML Topical Cream	SCD	d39922f0-c37c-fec3-e053-2995a90a141c	2
311678	metronidazole 0.75 % Topical Cream	SY	d39922f0-c37c-fec3-e053-2995a90a141c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-960-45	66993096045	1 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE	1 tube	2009-06-18	2027-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Topical Cream, 0.75% Rx only FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)	Prasco Laboratories \| DPT Laboratories Ltd. \| G Production Inc.	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	5
Metronidazole Topical Cream	DirectRx	2022-02-04	HUMAN PRESCRIPTION DRUG LABEL	2