FDA.reportPublic FDA data

DABIGATRAN

Product NDC
72205-203
11-digit product format
722050203
Labeler code
72205
Product ID
72205-203_50fb8204-a087-4f97-ab57-85773b8c0065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DABIGATRAN ETEXILATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213879
Marketing category
ANDA
Marketing start
2024-08-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DABIGATRAN
Listing expiration
2027-12-31

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-203-34DABIGATRAN6 in 1 CARTONCAPSULE64
72205-203-34DABIGATRAN10 in 1 BLISTER PACKCAPSULE104
72205-203-60DABIGATRAN60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-203-60EA - Each72205-2031167c2ac-0331-4ab3-b125-4728f01ddf2c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-203DABIGATRAN (DABIGATRAN ETEXILATE) CAPSULE [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, 3 package rows20241022_6f79088b-b353-485a-9df4-6f5088f5bd0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1723476dabigatran etexilate 110 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-203-34722050203346 BLISTER PACK in 1 CARTON (72205-203-34) / 10 CAPSULE in 1 BLISTER PACK6 blister pack2024-10-01NoNoCurrent
72205-203-607220502036060 CAPSULE in 1 BOTTLE (72205-203-60) 60 capsule2024-08-14NoNoCurrent