calcipotriene and betamethasone dipropionate (0713-0848)

Drug Facts

Product Profile

Brand Name calcipotriene and betamethasone dipropionate

Generic Name calcipotriene and betamethasone dipropionate

Labeler cosette pharmaceuticals, inc.

Dosage Form SUSPENSION

Routes

TOPICAL

Active Ingredients

betamethasone dipropionate .5 mg/g, calcipotriene 50 ug/g

Manufacturer

Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0848

Product ID 0713-0848_1f935790-9208-96ae-e063-6294a90ae07c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210765

Listing Expiration 2026-12-31

Marketing Start 2024-08-02

Pharmacologic Class

Established (EPC)

vitamin d analog [epc]

Chemical Structure

vitamin d [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130848

Hyphenated Format 0713-0848

Supplemental Identifiers

RxCUI

833461

UNII

826Y60901U 143NQ3779B

NUI

M0022797 N0000175849

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name calcipotriene and betamethasone dipropionate (source: ndc)

Generic Name calcipotriene and betamethasone dipropionate (source: ndc)

Application Number ANDA210765 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.5 mg/g
50 ug/g

source: ndc

Packaging

1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE
2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE

source: ndc

Packages (2)

0713-0848-60 1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE 0713-0848-92 2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE

Ingredients (2)

betamethasone dipropionate (.5 mg/g) calcipotriene (50 ug/g)

Linked Drug Pages (1)

calcipotriene and betamethasone dipropionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "1f935790-9208-96ae-e063-6294a90ae07c", "openfda": {"nui": ["M0022797", "N0000175849"], "unii": ["826Y60901U", "143NQ3779B"], "rxcui": ["833461"], "spl_set_id": ["1eba330b-ce18-6b12-e063-6294a90a8763"], "pharm_class_cs": ["Vitamin D [CS]"], "pharm_class_epc": ["Vitamin D Analog [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0713-0848-60)  / 60 g in 1 BOTTLE", "package_ndc": "0713-0848-60", "marketing_start_date": "20240802"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0713-0848-92)  / 60 g in 1 BOTTLE", "package_ndc": "0713-0848-92", "marketing_start_date": "20240802"}], "brand_name": "calcipotriene and betamethasone dipropionate", "product_id": "0713-0848_1f935790-9208-96ae-e063-6294a90ae07c", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Vitamin D Analog [EPC]", "Vitamin D [CS]"], "product_ndc": "0713-0848", "generic_name": "calcipotriene and betamethasone dipropionate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "calcipotriene and betamethasone dipropionate", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CALCIPOTRIENE", "strength": "50 ug/g"}], "application_number": "ANDA210765", "marketing_category": "ANDA", "marketing_start_date": "20240802", "listing_expiration_date": "20261231"}