FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
72865-272
11-digit product format
728650272
Labeler code
72865
Product ID
72865-272_3f2f2d85-443a-46a1-a637-69b106156df4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA207961
Marketing category
ANDA
Marketing start
2023-08-01
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
75 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 MESYLATE75 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-272-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-272-60EA - Each72865-272e390cc89-77e3-4d31-99ba-b42e6443a85c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-272DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE) CAPSULE [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240307_19b3bfc1-4fcb-4eb9-a611-02c27c05c56e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037045dabigatran etexilate 150 MG Oral CapsulePSN19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1
1037179dabigatran etexilate 75 MG Oral CapsulePSN19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1
1037045dabigatran etexilate 150 MG Oral CapsuleSCD19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1
1037179dabigatran etexilate 75 MG Oral CapsuleSCD19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY19b3bfc1-4fcb-4eb9-a611-02c27c05c56e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-272-607286502726060 CAPSULE in 1 BOTTLE (72865-272-60) 60 capsule2023-08-01NoNoHistorical