Metronidazole Gel USP, 0.75%

Manufacturer: Prugen, Inc.
Effective date: 2015-07-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:20:59

Label at a glance#

ProductMetronidazole

Active ingredientMetronidazole

Label structure11 sections

Indications and uses

Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Dosage and administration

Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.

Contacts and useful links#

Websitewww.prugen.com

www.prugen.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE

DESCRIPTION

DESCRIPTION SECTION

Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Bioavailability studies on the topical administration of 1 gram of metronidazole gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which metronidazole gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Metronidazole gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients

INFORMATION FOR PATIENTS SECTION

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug interactions

DRUG INTERACTIONS SECTION

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy

PREGNANCY SECTION

Teratogenic effects

TERATOGENIC EFFECTS SECTION

Pregnancy category B

SPL UNCLASSIFIED SECTION

There has been no experience to date with the use of metronidazole gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

NURSING MOTHERS SECTION

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole gel blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.

HOW SUPPLIED

HOW SUPPLIED SECTION

Metronidazole Gel USP, 0.75% is supplied in aluminum tubes containing:
45 g NDC 42546-700-45

STORAGE AND HANDLING SECTION

Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

SPL UNCLASSIFIED SECTION

Mfd. for:
PruGen Pharmaceuticals
Scottsdale, AZ 85255
www.prugen.com
Rev 2.0

Made in Israel

Revised: April, 2015

20768-0415-0 705

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42546-700-45

45 g

Rx only

Metronidazole
GEL USP, 0.75%

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

PRUGEN™
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311679	metroNIDAZOLE 0.75 % Topical Gel	PSN	1
311679	metronidazole 0.0075 MG/MG Topical Gel	SCD	1
311679	metronidazole 0.75 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
METRONIDAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
42546-700-45	2020-01-31	C162847	48780-1	9d75b9d0-1ac5-f424-e053-dadaa90a57ce	Metronidazole Gel USP, 0.75%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42546-700-45	Metronidazole	1 in 1 CARTON	GEL	1		1
42546-700-45	Metronidazole	45 g in 1 TUBE	GEL	45		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42546-700	METRONIDAZOLE GEL [PRUGEN, INC.]	1	Legacy NDC, 2 package rows	20150731_8fbbbd41-dfeb-4e02-9a50-653a2c2c03d4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-700-45	GM - Gram	42546-700	87f67de4-c3c5-44d5-8ab1-f8ebcfcd7619	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Metronidazole	ACTIVE INGREDIENT	140QMO216E	1
Metronidazole	ACTIVE MOIETY	140QMO216E	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Metronidazole
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
edetate disodium
methylparaben
propylene glycol
propylparaben
water
sodium hydroxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42546-700	42546-700-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Metronidazole	140QMO216E	ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
edetate disodium	7FLD91C86K	IACT
methylparaben	A2I8C7HI9T	IACT
propylene glycol	6DC9Q167V3	IACT
propylparaben	Z8IX2SC1OH	IACT
water	059QF0KO0R	IACT
sodium hydroxide	55X04QC32I	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 488 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	LOTION / TOPICAL		300 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	EMULSION / TOPICAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077819-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2006-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077819-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077819-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077819-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077819-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077819-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077819-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077819-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077819-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077819-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077819-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077819-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077819-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077819-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077819-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077819-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077819-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077819-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077819-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077819-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077819-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077819-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077819-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077819-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077819-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077819-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077819-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077819-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077819-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077819-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077819-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077819-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077819-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077819-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077819-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077819-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077819-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077819-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077819-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077819-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077819-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077819-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077819-001	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e8f3ea4a-435c-4869-9fb0-4ac62cbbd049			8fbbbd41-dfeb-4e02-9a50-653a2c2c03d4	2015-07-29	Adverse reactions	Exact identifier spl id: e8f3ea4a-435c-4869-9fb0-4ac62cbbd049 spl set id: 8fbbbd41-dfeb-4e02-9a50-653a2c2c03d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.