FDA Drug Listing Form — Regovant LLC

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Labeler Information

Must match exactly as listed in the NDC Labeler Code

The Labeler name must be identical to the name registered with the NDC Labeler Code. Any discrepancy may result in listing rejection.

Labeler Name *

Labeler DUNS Number *

Name of Contact Person *

Phone Number *

Labeler Business Type *

Own-Label Manufacturer ? Private Label Distributor (PLD) ? Contract Manufacturer ? API Manufacturer ? Packer Labeler Relabeler Repacker Transfiller

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Manufacturer

Name of establishment manufacturing the drug product

Manufacturer Name *

Manufacturer DUNS Number

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Drug Product Information

Brand name, intended use, and marketing details

Proprietary Name (Brand Name) *

Proprietary Name Suffix (e.g. Extra Strength, PM)

Intended Use of the Drug *

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Packaging Information

Inner & outer package details, NDC Labeler Code, and label image

Inner Package

Package Type

Labeler Code (10 digits)

Quantity / Count

Outer Package

Package Type

Labeler Code * (10 digits)

Quantity / Count

Attach Label Image

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Click to upload label image

Accepted formats: JPG, PNG, PDF — Max 10MB

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DEA Schedule & Drug Characteristics

Select DEA schedule if applicable and describe physical characteristics

DEA Schedule (if applicable — select one)

Characteristics

Route of Administration *

Dosage Form

Flavor (if applicable)

Color

Shape

Size (mm)

Scoring

Imprint Information (text or code printed/embossed on dosage form)

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Marketing Information

Marketing dates, category, and quantity details

Marketing Start Date *

Marketing End Date (if discontinued)

Quantity (Net Weight) *

Marketing Category (if OTC Monograph, enter Monograph Number)

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Active Ingredients

List all active ingredients, strength, and UNII (if known)

#	Active Ingredient (e.g. Avobenzone)	Strength (e.g. 200mg in 1 mL)	UNII (Unique Ingredient Identifier, if known)

Please use an additional form if you have more than 8 active ingredients.

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Inactive Ingredients

List all inactive ingredients and UNII (if known) — strength is optional

#	Inactive Ingredient (e.g. Water)	Strength (Optional)	UNII (if known)

Please use an additional form if you have more inactive ingredients than listed. Strength is optional for inactive ingredients.

Other Information (if any)

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Terms, Conditions & Certification

📜 Terms and Conditions

By submitting this drug listing form, the submitter certifies that:

1. The drug product(s) listed on this form are currently marketed or will be marketed in the United States.

2. All information provided is true and accurate to the best of the submitter's knowledge and belief.

3. The submitter is authorized to submit this listing on behalf of the labeler.

4. The labeler will update this listing whenever any information changes, and will renew annually as required by 21 CFR Part 207.

5. Under 18 U.S.C. §1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.

6. Drug listing does not constitute FDA approval or clearance of the drug product.

I agree to the above Terms and Conditions *

Submitter Information

Submitter Name *

Job Title *

Submitter E-mail *

Signature (typed) *

Date

Drug Listing Form

Labeler Information

Manufacturer

Drug Product Information

Packaging Information

DEA Schedule & Drug Characteristics

Marketing Information

Active Ingredients

Inactive Ingredients

Terms, Conditions & Certification

Listing Submitted