clindamycin phosphate and tretinoin gel 1.2%/0.025%

Generic: clindamycin phosphate and tretinoin gel 1.2%/0.025%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate and tretinoin gel 1.2%/0.025%
Generic Name clindamycin phosphate and tretinoin gel 1.2%/0.025%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/g, tretinoin .25 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-050
Product ID 21922-050_854a8cf5-cfcf-4189-af34-e111363266a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216943
Listing Expiration 2026-12-31
Marketing Start 2023-09-04

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922050
Hyphenated Format 21922-050

Supplemental Identifiers

RxCUI
882548
UPC
0321922050073 0321922050059
UNII
EH6D7113I8 5688UTC01R
NUI
N0000175607 M0018962

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 clindamycin phosphate and tretinoin gel 1.2%/0.025% (source: ndc)
Generic Name clindamycin phosphate and tretinoin gel 1.2%/0.025% (source: ndc)
Application Number ANDA216943 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE
source: ndc

Packages (2)

21922-050-05 1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE 21922-050-07 1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE

Ingredients (2)

clindamycin phosphate (10 mg/g) tretinoin (.25 mg/g)

Linked Drug Pages (1)

Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "854a8cf5-cfcf-4189-af34-e111363266a1", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0321922050073", "0321922050059"], "unii": ["EH6D7113I8", "5688UTC01R"], "rxcui": ["882548"], "spl_set_id": ["1f772408-52a3-45b2-b053-8fc78948983c"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-050-05)  / 30 g in 1 TUBE", "package_ndc": "21922-050-05", "marketing_start_date": "20230904"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-050-07)  / 60 g in 1 TUBE", "package_ndc": "21922-050-07", "marketing_start_date": "20230904"}], "brand_name": "Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%", "product_id": "21922-050_854a8cf5-cfcf-4189-af34-e111363266a1", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]", "Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "21922-050", "generic_name": "Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}, {"name": "TRETINOIN", "strength": ".25 mg/g"}], "application_number": "ANDA216943", "marketing_category": "ANDA", "marketing_start_date": "20230904", "listing_expiration_date": "20261231"}