Acitretin

Product NDC
62332-741
11-digit product format
623320741
Labeler code
62332
Product ID
62332-741_1235e7ee-d6db-440e-a680-999dc3295d2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acitretin
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217774
Marketing category
ANDA
Marketing start
2024-08-08
Substance
ACITRETIN
Active strength
10 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acitretin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACITRETIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLCH760E9T7
Rxcui199689, 199690, 894859

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1de339d8-426e-ddd1-e402-3d0883adaab0Product name620250312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-741-30Acitretin30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-741-30EA - Each62332-741a8947ba3-48c0-45c7-a665-d39106158d4912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-741ACITRETIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 1 package rows20240810_0a4ca401-6ea4-4653-8674-056fa637f4a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199689acitretin 10 MG Oral CapsulePSN0a4ca401-6ea4-4653-8674-056fa637f4a15
894859acitretin 17.5 MG Oral CapsulePSN0a4ca401-6ea4-4653-8674-056fa637f4a15
199690acitretin 25 MG Oral CapsulePSN0a4ca401-6ea4-4653-8674-056fa637f4a15
199689acitretin 10 MG Oral CapsuleSCD0a4ca401-6ea4-4653-8674-056fa637f4a15
894859acitretin 17.5 MG Oral CapsuleSCD0a4ca401-6ea4-4653-8674-056fa637f4a15
199690acitretin 25 MG Oral CapsuleSCD0a4ca401-6ea4-4653-8674-056fa637f4a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-741-306233207413030 CAPSULE in 1 BOTTLE (62332-741-30) 30 capsule2024-08-08NoNoCurrent