retin-a micro

Generic: tretinoin

Labeler: bausch health us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name retin-a micro
Generic Name tretinoin
Labeler bausch health us llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .4 mg/g

Manufacturer
Bausch Health US LLC

Identifiers & Regulatory

Product NDC 0187-5144
Product ID 0187-5144_5eacf7df-7bdd-4401-ae28-2319c8757b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020475
Listing Expiration 2027-12-31
Marketing Start 2002-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875144
Hyphenated Format 0187-5144

Supplemental Identifiers

RxCUI
313453 359050 805370 805372 1488045 1488047 1987644 1987646
UNII
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 retin-a micro (source: ndc)
Generic Name tretinoin (source: ndc)
Application Number NDA020475 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/g
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RETIN-A MICRO (tretinoin) gel is opaque and white to very pale yellow in color and is supplied as follows: Strength Amount of Tretinoin in One Gram of Gel Quantity/Package Type NDC 0.04% 0.4 mg 20 gram tube 0187-5144-20 45 gram tube 0187-5144-45 50 gram pump 0187-5144-50 0.06% 0.6 mg 50 gram pump 0187-5146-50 0.08% 0.8 mg 50 gram pump 0187-5148-50 0.1% 1 mg 20 gram tube 0187-5140-20 45 gram tube 0187-5140-45 50 gram pump 0187-5140-50 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store pump upright.
  • PRINCIPAL DISPLAY PANEL - 0.08% 50 g Carton NDC 0187-5148-50 RETIN-A MICRO ® (tretinoin) Gel microsphere 0.08% PUMP For Topical Use Only Rx Only Ortho Dermatologics NET WT. 50 g 9440608 20000365J 0.08pct carton
  • PRINCIPAL DISPLAY PANEL - 0.06% 50 g Carton NDC 0187-5146-50 RETIN-A MICRO ® tretinoin Gel (microsphere) 0.06% PUMP For Topical Use Only Rx only Ortho Dermatologics NET WT. 50 g 9581504 20001795E 0.06pct carton
  • PRINCIPAL DISPLAY PANEL - 0.04% 50 g Carton NDC 0187-5144-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.04% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450907 0.04pct carton
  • PRINCIPAL DISPLAY PANEL - 0.1% 50 g Carton NDC 0187-5140-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.1% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450707 0.1pct carton
source: label

Packages (0)

No package records.

Ingredients (1)

tretinoin (.4 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "5eacf7df-7bdd-4401-ae28-2319c8757b4a", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["313453", "359050", "805370", "805372", "1488045", "1488047", "1987644", "1987646"], "spl_set_id": ["08ab7e0c-1437-455f-815c-98904d96a289"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Retin-A MICRO", "product_id": "0187-5144_5eacf7df-7bdd-4401-ae28-2319c8757b4a", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0187-5144", "generic_name": "Tretinoin", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Retin-A MICRO", "active_ingredients": [{"name": "TRETINOIN", "strength": ".4 mg/g"}], "application_number": "NDA020475", "marketing_category": "NDA", "marketing_start_date": "20020510", "listing_expiration_date": "20271231"}