FDA.reportPublic FDA data

dabigatran etexilate

Product NDC
60505-4349
11-digit product format
605054349
Labeler code
60505
Product ID
60505-4349_34169945-6c2a-c534-5f38-eeafa24cd108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dabigatran etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208070
Marketing category
ANDA
Marketing start
2024-02-13
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-434960505-4349-2DDiscontinued by firm2026-07-31

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
A208070-001DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2023-12-15
A208070-002DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2023-12-15
A208070-003DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2023-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208070-001AB
A208070-002AB
A208070-003AB

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 22:54:322026-06A208070-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2023-12-15a50c72e98297…
2026-08-01 22:54:322026-06A208070-002DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2023-12-15a50c72e98297…
2026-08-01 22:54:322026-06A208070-003DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2023-12-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208070-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208070-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208070-003AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dabigatran etexilateDABIGATRAN ETEXILATEApotex Corp.dd47a015-ff90-d7a7-8dcb-4e6e31a680712026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208070
application number: ANDA208070
ndc (product): 60505-4349

Additional Listing Data#

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

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
dd47a015-ff90-d7a7-8dcb-4e6e31a68071Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4349-2dabigatran etexilate10 in 1 CARTONCAPSULE104
60505-4349-2dabigatran etexilate60 in 1 BLISTER PACKCAPSULE604
60505-4349-6dabigatran etexilate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4349-6EA - Each60505-43493f259281-f9b9-49c2-98f4-d73cc98e53eb12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4349DABIGATRAN ETEXILATE CAPSULE [APOTEX CORP.]3Current NDC, 3 package rows20250413_dd47a015-ff90-d7a7-8dcb-4e6e31a68071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG Oral CapsulePSNdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1723476dabigatran etexilate 110 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG Oral CapsuleSCDdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSYdd47a015-ff90-d7a7-8dcb-4e6e31a680714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4349-26050543490210 in 1 CARTONHistorical
60505-4349-66050543490660 CAPSULE in 1 BOTTLE (60505-4349-6) 60 capsule2024-02-13NoNoCurrent