FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
31722-621
11-digit product format
317220621
Labeler code
31722
Product ID
31722-621_3b236998-0037-d34f-e063-6294a90a03f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA207961
Marketing category
ANDA
Marketing start
2020-05-06
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, 1723476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-621-32Dabigatran Etexilate6 in 1 BLISTER PACKCAPSULE68
31722-621-32Dabigatran Etexilate10 in 1 CARTONCAPSULE108
31722-621-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-621-32EA - Each31722-6217c6e2e29-5756-4b2c-93f2-888a12cab32512025-03-04
31722-621-60EA - Each31722-62101af66c8-cd16-41c3-93f3-32bff3fef06212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-621DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20250213_3c24e235-218b-438e-9456-42c18ff01913.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1723476dabigatran etexilate 110 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-621-323172206213210 BLISTER PACK in 1 CARTON (31722-621-32) / 6 CAPSULE in 1 BLISTER PACK10 blister pack2025-02-03NoNoHistorical
31722-621-603172206216060 CAPSULE in 1 BOTTLE (31722-621-60) 60 capsule2020-05-060000-00-00NoNoCurrent