Acitretin

Product NDC
0093-1136
11-digit product format
000931136
Labeler code
0093
Product ID
0093-1136_11579624-a4a1-4db1-bf72-9fbedbce3225
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acitretin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091455
Marketing category
ANDA
Marketing start
2013-07-19
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
0093-1136-56Acitretin30 in 1 BOTTLECAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1136ACITRETIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 1 package rows20220911_993a5325-cd10-4450-b5ea-1c0a90510df6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199689acitretin 10 MG Oral CapsulePSN993a5325-cd10-4450-b5ea-1c0a90510df615
894859acitretin 17.5 MG Oral CapsulePSN993a5325-cd10-4450-b5ea-1c0a90510df615
199690acitretin 25 MG Oral CapsulePSN993a5325-cd10-4450-b5ea-1c0a90510df615
199689acitretin 10 MG Oral CapsuleSCD993a5325-cd10-4450-b5ea-1c0a90510df615
894859acitretin 17.5 MG Oral CapsuleSCD993a5325-cd10-4450-b5ea-1c0a90510df615
199690acitretin 25 MG Oral CapsuleSCD993a5325-cd10-4450-b5ea-1c0a90510df615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-1136-000009311360010000 CAPSULE in 1 BOX (0093-1136-00)10000 capsule01-NOV-21Current
0093-1136-560009311365630 CAPSULE in 1 BOTTLE (0093-1136-56) 30 capsule2013-07-190000-00-00NoNoCurrent