FDA.reportPublic FDA data

dabigatran etexilate

Product NDC
60505-4349
11-digit product format
605054349
Labeler code
60505
Product ID
60505-4349_34169945-6c2a-c534-5f38-eeafa24cd108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dabigatran etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208070
Marketing category
ANDA
Marketing start
2024-02-13
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
110 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 MESYLATE110 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSC7NUW5IIT
Rxcui1037045, 1037179, 1723476

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
60505-4349-2dabigatran etexilate10 in 1 CARTONCAPSULE104
60505-4349-2dabigatran etexilate60 in 1 BLISTER PACKCAPSULE604
60505-4349-6dabigatran etexilate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4349-6EA - Each60505-43493f259281-f9b9-49c2-98f4-d73cc98e53eb12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4349DABIGATRAN ETEXILATE CAPSULE [APOTEX CORP.]3Current NDC, 3 package rows20250413_dd47a015-ff90-d7a7-8dcb-4e6e31a68071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1723476dabigatran etexilate 110 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4349-26050543490210 in 1 CARTONHistorical
60505-4349-66050543490660 CAPSULE in 1 BOTTLE (60505-4349-6) 60 capsule2024-02-13NoNoHistorical