clotrimazole and betamethasone dipropionate

Generic: clotrimazole and betamethasone dipropionate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole and betamethasone dipropionate
Generic Name clotrimazole and betamethasone dipropionate
Labeler northstar rx llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

betamethasone dipropionate .5 mg/g, clotrimazole 10 mg/g

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-496
Product ID 16714-496_a702b9ac-d29c-4465-b3dd-64576a2c10e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075673
Listing Expiration 2026-12-31
Marketing Start 2001-05-29

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714496
Hyphenated Format 16714-496

Supplemental Identifiers

RxCUI
308714
UNII
826Y60901U G07GZ97H65
NUI
N0000175487 M0002083

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 clotrimazole and betamethasone dipropionate (source: ndc)
Generic Name clotrimazole and betamethasone dipropionate (source: ndc)
Application Number ANDA075673 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16714-496-01) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16714-496-02) / 45 g in 1 TUBE
source: ndc

Packages (2)

16714-496-01 1 TUBE in 1 CARTON (16714-496-01) / 15 g in 1 TUBE 16714-496-02 1 TUBE in 1 CARTON (16714-496-02) / 45 g in 1 TUBE

Ingredients (2)

betamethasone dipropionate (.5 mg/g) clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole and Betamethasone Dipropionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a702b9ac-d29c-4465-b3dd-64576a2c10e2", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["826Y60901U", "G07GZ97H65"], "rxcui": ["308714"], "spl_set_id": ["8d03b9ba-f7a8-4fbf-9be1-83d815c2be45"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16714-496-01)  / 15 g in 1 TUBE", "package_ndc": "16714-496-01", "marketing_start_date": "20160815"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16714-496-02)  / 45 g in 1 TUBE", "package_ndc": "16714-496-02", "marketing_start_date": "20160815"}], "brand_name": "Clotrimazole and Betamethasone Dipropionate", "product_id": "16714-496_a702b9ac-d29c-4465-b3dd-64576a2c10e2", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "16714-496", "generic_name": "Clotrimazole and Betamethasone Dipropionate", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole and Betamethasone Dipropionate", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA075673", "marketing_category": "ANDA", "marketing_start_date": "20010529", "listing_expiration_date": "20261231"}