FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
67877-475
11-digit product format
678770475
Labeler code
67877
Product ID
67877-475_dd84fc7b-8d68-4a2b-ab48-9458f6586160
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208040
Marketing category
ANDA
Marketing start
2022-06-20
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, 1723476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-475-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE, COATED PELLETS6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-475-60EA - Each67877-4751a840279-4122-49eb-a1ec-a605256f5dfc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-475DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 1 package rows20241012_3a8ec82a-c367-40dc-9302-e1896fcb05ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037045dabigatran etexilate 150 MG Oral CapsulePSN3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037179dabigatran etexilate 75 MG Oral CapsulePSN3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1723476dabigatran etexilate 110 MG Oral CapsuleSCD3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037045dabigatran etexilate 150 MG Oral CapsuleSCD3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037179dabigatran etexilate 75 MG Oral CapsuleSCD3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY3a8ec82a-c367-40dc-9302-e1896fcb05ea26
1037045dabigatran etexilate 150 MG Oral CapsulePSN369b945d-5bda-4773-910a-d0adef7f0f391
1037045dabigatran etexilate 150 MG Oral CapsuleSCD369b945d-5bda-4773-910a-d0adef7f0f391
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY369b945d-5bda-4773-910a-d0adef7f0f391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-475-606787704756060 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-475-60) 2022-06-200000-00-00NoNoCurrent