FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
67877-624
11-digit product format
678770624
Labeler code
67877
Product ID
67877-624_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
2025-09-12
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208040-001DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2020-03-11
A208040-002DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2020-03-11
A208040-003DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208040-001AB
A208040-002AB
A208040-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208040-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2020-03-11a50c72e98297…
2026-08-01 22:54:322026-06A208040-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2020-03-11a50c72e98297…
2026-08-01 22:54:322026-06A208040-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208040-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208040-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208040-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dabigatran EtexilateDABIGATRAN ETEXILATEA-S Medication Solutionsb31d27e9-5502-43c5-83fa-89608c014b7a2025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208040
application number: ANDA208040
Dabigatran EtexilateDABIGATRAN ETEXILATEA-S Medication Solutions369b945d-5bda-4773-910a-d0adef7f0f392025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208040
application number: ANDA208040
Dabigatran EtexilateDABIGATRAN ETEXILATEAscend Laboratories, LLC3a8ec82a-c367-40dc-9302-e1896fcb05ea2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208040
application number: ANDA208040
ndc (product): 67877-624
Dabigatran EtexilateDABIGATRAN ETEXILATEMajor Pharmaceuticalsb76b79ce-b7dd-4390-b40e-71ae6c477d102025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208040
application number: ANDA208040

Additional Listing Data#

Finished product
Yes
Brand name base
Dabigatran Etexilate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE110 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SC7NUW5IITInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1037045Internal RxNorm lookup
1037179Internal RxNorm lookup
1723476Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a8ec82a-c367-40dc-9302-e1896fcb05eaAvailable on FDA.report

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
67877-624-31Dabigatran Etexilate6 in 1 BLISTER PACKCAPSULE, COATED PELLETS626
67877-624-31Dabigatran Etexilate10 in 1 CARTONCAPSULE, COATED PELLETS1026
67877-624-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE, COATED PELLETS6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-624-60EA - Each67877-62497382bd0-9466-4ef2-b753-83f2a60bebde12025-10-14

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-624-316787706243110 BLISTER PACK in 1 CARTON (67877-624-31) / 6 CAPSULE, COATED PELLETS in 1 BLISTER PACK10 blister pack2025-09-12NoNoCurrent
67877-624-606787706246060 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-624-60) 2025-09-12NoNoCurrent