What is NDC 0713-0804?

0713-0804 is the product NDC for Tazarotene, Tazarotene 1 mg/g gel, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tazarotene?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tazarotene NDC 0713-0804 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0804Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0713-0804-31	0071308043100713080431	1 TUBE in 1 CARTON (0713-0804-31) / 30 g in 1 TUBEMarketed from Sep 14, 2022
0713-0804-99	0071308049900713080499	1 TUBE in 1 CARTON (0713-0804-99) / 100 g in 1 TUBEMarketed from Sep 14, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tazarotene
Generic name (nonproprietary): tazarotene
Active ingredients: Tazarotene — 1 mg/g
Dosage form: Gel
Route: Topical
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214136
Marketing start: Sep 14, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0713-0804_0b4b0b29-a411-44a4-e063-6294a90ab3baSPL ID 0b4b0b29-a411-44a4-e063-6294a90ab3baSPL set ID 94749b8e-0d00-4257-a660-6d0fc8815fcfRxCUI 313201UNII 81BDR9Y8PS
Pharmacologic class: Retinoid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400713080431 followed by a unit qualifier and the quantity

Package 00713-0804-31. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 29, 2023.

Indications (excerpt from the label)

Tazarotene gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 Plaque Psoriasis Tazarotene gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0804

What is NDC 0713-0804?: 0713-0804 is the product NDC for Tazarotene, Tazarotene 1 mg/g gel, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tazarotene.
What is the active ingredient?: Tazarotene.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tazarotene?: 14 other product NDCs are listed under this name. See all Tazarotene NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tazarotene NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tazarotene	Tazarotene .5 mg/g	CreamTopical	Cosette Pharmaceuticals, Inc.	0713-0765	00713-0765-3100713-0765-60
Tazarotene	Tazarotene .5 mg/g	GelCutaneous	Solaris Pharma Corporation	73473-309	73473-0309-1073473-0309-30
Tazarotene	Tazarotene 1 mg/g	GelCutaneous	Solaris Pharma Corporation	73473-310	73473-0310-1073473-0310-30
Tazarotene	Tazarotene .5 mg/g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-706	45802-0706-9445802-0706-96
Tazarotene	Tazarotene .5 mg/g	CreamTopical	Bryant Ranch Prepack	72162-2420	72162-2420-0372162-2420-06
Tazarotene	Tazarotene .5 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-436	45802-0436-0145802-0436-94
Tazarotene	Tazarotene 1 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-442	45802-0442-0145802-0442-94
Tazarotene	Tazarotene 1 mg/g	GelTopical	Bryant Ranch Prepack	72162-2202	72162-2202-03
Tazarotene	Tazarotene .5 mg/g	GelTopical	Cosette Pharmaceuticals, Inc.	0713-0805	00713-0805-3100713-0805-99
Tazarotene	Tazarotene 1 mg/g	CreamTopical	Mayne Pharma	68308-745	68308-0745-30

All 15 Tazarotene NDCs

Other NDCs under ANDA 214136

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214136
Product	Strength	Form · route	Labeler	Product NDC
Trilitastazarotene	Tazarotene 1 mg/g	GelTopical	Perfero Pharma, Inc.	87143-200