ACITRETIN

Product NDC
42291-088
11-digit product format
422910088
Labeler code
42291
Product ID
42291-088_0e8b3503-2371-af12-e063-6294a90af0c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACITRETIN
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA204633
Marketing category
ANDA
Marketing start
2017-10-11
Substance
ACITRETIN
Active strength
25 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
ACITRETIN25 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
42291-088-30ACITRETIN30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-088-30EA - Each42291-088da73cfe0-46bd-43b2-ac28-c047bb5f1ca612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-088ACITRETIN CAPSULE [AVKARE]7Current NDC, Legacy NDC, 1 package rows20240124_6af396c2-af3e-436d-ba9a-583637495910.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199689acitretin 10 MG Oral CapsulePSN6af396c2-af3e-436d-ba9a-5836374959107
894859acitretin 17.5 MG Oral CapsulePSN6af396c2-af3e-436d-ba9a-5836374959107
199690acitretin 25 MG Oral CapsulePSN6af396c2-af3e-436d-ba9a-5836374959107
199689acitretin 10 MG Oral CapsuleSCD6af396c2-af3e-436d-ba9a-5836374959107
894859acitretin 17.5 MG Oral CapsuleSCD6af396c2-af3e-436d-ba9a-5836374959107
199690acitretin 25 MG Oral CapsuleSCD6af396c2-af3e-436d-ba9a-5836374959107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-088-304229100883030 CAPSULE in 1 BOTTLE (42291-088-30) 30 capsule2017-10-110000-00-00NoNoCurrent