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NDC 63646-0040-60 calcipotriene and betamethasone dipropionate .5; 50 mg/g; ug/g Details
calcipotriene and betamethasone dipropionate .5; 50 mg/g; ug/g
calcipotriene and betamethasone dipropionate is a TOPICAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TOLMAR Inc.. The primary component is BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE.
MedlinePlus Drug Summary
Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Betamethasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 63646-0040-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Betamethasone Topical
Calcipotriene is used to treat psoriasis (a skin disease in which red, scaly patches form due to increased production of skin cells on some areas of the body). Calcipotriene is in a class of medications called synthetic vitamin D3 derivatives. It works by slowing the excessive production of skin cells.
Related Packages: 63646-0040-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcipotriene Topical
Product Information
| NDC | 63646-0040 |
|---|---|
| Product ID | 63646-040_b4d1b2b3-8962-409c-95cc-b0917b0b1980 |
| Associated GPIs | 90559902321825 |
| GCN Sequence Number | 063988 |
| GCN Sequence Number Description | calcipotriene/betamethasone SUSPENSION 0.005-.064 TOPICAL |
| HIC3 | T0A |
| HIC3 Description | TOPICAL VIT D ANALOG/ANTI-INFLAMMATORY STEROID |
| GCN | 99699 |
| HICL Sequence Number | 022851 |
| HICL Sequence Number Description | CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE |
| Brand/Generic | Generic |
| Proprietary Name | calcipotriene and betamethasone dipropionate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | calcipotriene and betamethasone dipropionate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | TOPICAL |
| Active Ingredient Strength | .5; 50 |
| Active Ingredient Units | mg/g; ug/g |
| Substance Name | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
| Labeler Name | TOLMAR Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210765 |
| Listing Certified Through | n/a |
Package
NDC 63646-0040-60 (63646004060)
| NDC Package Code | 63646-040-60 |
|---|---|
| Billing NDC | 63646004060 |
| Package | 1 BOTTLE in 1 CARTON (63646-040-60) / 60 g in 1 BOTTLE |
| Marketing Start Date | 2020-05-11 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 3.10467 |
| Pricing Unit | GM |
| Effective Date | 2023-01-18 |
| NDC Description | CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% SUSPENSION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-01-10 |