FDA.reportPublic FDA data

DABIGATRAN

Product NDC
50268-200
11-digit product format
502680200
Labeler code
50268
Product ID
50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DABIGATRAN ETEXILATE
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA213879
Marketing category
ANDA
Marketing start
2025-07-12
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

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
A213879-001DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22
A213879-002DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22
A213879-003DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213879-001AB
A213879-002AB
A213879-003AB

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 22:54:322026-06A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22a50c72e98297…
2026-08-01 22:54:322026-06A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22a50c72e98297…
2026-08-01 22:54:322026-06A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213879-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213879-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213879-003AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DABIGATRANDABIGATRAN ETEXILATEAmerican Health Packagingf7ea7e2c-ca54-4ecc-9fc7-bd3571b0ebc22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879
DABIGATRANDABIGATRAN ETEXILATENovadoz Pharmaceuticals LLC6f79088b-b353-485a-9df4-6f5088f5bd0f2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879
DABIGATRANDABIGATRAN ETEXILATEAvKARE27e95caf-7938-ef8e-e063-6394a90a6a1a2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879
DABIGATRANDABIGATRAN ETEXILATEAvPAK39ac558a-b375-f3c1-e063-6394a90aa9012025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879
ndc (product): 50268-200
DABIGATRANDABIGATRAN ETEXILATEA-S Medication Solutionsbee57f1b-ee5f-4f81-ae6f-ea65ddf9a1742025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879
DABIGATRANDABIGATRAN ETEXILATEA-S Medication Solutionse4e3b992-621a-43a5-be59-eeb5083fd2b42025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213879
application number: ANDA213879

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE150 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39ac558a-b375-f3c1-e063-6394a90aa901Available 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-200-11DABIGATRAN1 in 1 BLISTER PACKCAPSULE12
50268-200-16DABIGATRAN60 in 1 BOXCAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-200-11EA - Each50268-20079213190-1882-4842-b4f6-e3bc08ec96bf12025-08-11
50268-200-16EA - Each50268-200d1e377be-c06a-4806-a77c-1a4a2985317d12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-200-11502680200111 in 1 BLISTER PACKHistorical
50268-200-165026802001660 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11) 60 blister pack2025-07-12NoNoCurrent