FDA.reportPublic FDA data

DABIGATRAN

Product NDC
72205-204
11-digit product format
722050204
Labeler code
72205
Product ID
72205-204_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
2024-05-22
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
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 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
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-204-34DABIGATRAN10 in 1 BLISTER PACKCAPSULE104
72205-204-34DABIGATRAN6 in 1 CARTONCAPSULE64
72205-204-60DABIGATRAN60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-204-60EA - Each72205-204238462d4-a97b-4854-9fd4-57e1e530d59112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-204DABIGATRAN (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
1037045dabigatran etexilate 150 MG Oral CapsulePSN39ac558a-b375-f3c1-e063-6394a90aa9012
1037045dabigatran etexilate 150 MG Oral CapsuleSCD39ac558a-b375-f3c1-e063-6394a90aa9012
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY39ac558a-b375-f3c1-e063-6394a90aa9012
1037045dabigatran etexilate 150 MG Oral CapsulePSNe4e3b992-621a-43a5-be59-eeb5083fd2b41
1037045dabigatran etexilate 150 MG Oral CapsuleSCDe4e3b992-621a-43a5-be59-eeb5083fd2b41
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYe4e3b992-621a-43a5-be59-eeb5083fd2b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-204-34722050204346 BLISTER PACK in 1 CARTON (72205-204-34) / 10 CAPSULE in 1 BLISTER PACK6 blister pack2024-10-01NoNoCurrent
72205-204-607220502046060 CAPSULE in 1 BOTTLE (72205-204-60) 60 capsule2024-05-24NoNoCurrent