FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
0378-0266
11-digit product format
003780266
Labeler code
0378
Product ID
0378-0266_6c6b985e-111f-4fe9-a1ca-785c450e444b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA208067
Marketing category
ANDA
Marketing start
2025-02-25
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
150 mg/1
Pharmacologic classes
Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSC7NUW5IIT
Rxcui1037045, 1037179

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0266-91Dabigatran Etexilate60 in 1 BOTTLE, PLASTICCAPSULE604
0378-0266-93Dabigatran Etexilate30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0266-91EA - Each0378-0266a4e67c82-880e-40c1-9006-f98cff20b0e012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0266DABIGATRAN ETEXILATE CAPSULE [MYLAN PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250302_baafb5be-ffe6-4755-a7ab-817b3c9b222d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037045dabigatran etexilate 150 MG Oral CapsulePSNbaafb5be-ffe6-4755-a7ab-817b3c9b222d4
1037179dabigatran etexilate 75 MG Oral CapsulePSNbaafb5be-ffe6-4755-a7ab-817b3c9b222d4
1037045dabigatran etexilate 150 MG Oral CapsuleSCDbaafb5be-ffe6-4755-a7ab-817b3c9b222d4
1037179dabigatran etexilate 75 MG Oral CapsuleSCDbaafb5be-ffe6-4755-a7ab-817b3c9b222d4
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYbaafb5be-ffe6-4755-a7ab-817b3c9b222d4
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSYbaafb5be-ffe6-4755-a7ab-817b3c9b222d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0378-0266-910037802669160 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91) 60 capsule2025-02-25NoNoCurrent
0378-0266-930037802669330 in 1 BOTTLE, PLASTICHistorical