FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
46708-634
11-digit product format
467080634
Labeler code
46708
Product ID
46708-634_4f8d4596-bc1a-48a1-8f6a-caf816a2037f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215233
Marketing category
ANDA
Marketing start
2024-06-14
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
75 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
A215233-001DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14
A215233-002DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14
A215233-003DABIGATRAN 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
A215233-001AB
A215233-002AB
A215233-003AB

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 22:54:322026-06A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14a50c72e98297…
2026-08-01 22:54:322026-06A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14a50c72e98297…
2026-08-01 22:54:322026-06A215233-003DABIGATRAN 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 22:54:322026-06A215233-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A215233-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A215233-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Limited13649035-a498-4e31-a7ea-8b18cedceca72025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215233
application number: ANDA215233
ndc (product): 46708-634
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Inc.834a3c5f-b723-4bcb-a560-dc305dd0d8292025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215233
application number: ANDA215233

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE75 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
13649035-a498-4e31-a7ea-8b18cedceca7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-634-06Dabigatran Etexilate10 in 1 CARTONCAPSULE103
46708-634-06Dabigatran Etexilate6 in 1 BLISTER PACKCAPSULE63
46708-634-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-634DABIGATRAN ETEXILATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, 3 package rows20240817_13649035-a498-4e31-a7ea-8b18cedceca7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN13649035-a498-4e31-a7ea-8b18cedceca73
1037045dabigatran etexilate 150 MG Oral CapsulePSN13649035-a498-4e31-a7ea-8b18cedceca73
1037179dabigatran etexilate 75 MG Oral CapsulePSN13649035-a498-4e31-a7ea-8b18cedceca73
1723476dabigatran etexilate 110 MG Oral CapsuleSCD13649035-a498-4e31-a7ea-8b18cedceca73
1037045dabigatran etexilate 150 MG Oral CapsuleSCD13649035-a498-4e31-a7ea-8b18cedceca73
1037179dabigatran etexilate 75 MG Oral CapsuleSCD13649035-a498-4e31-a7ea-8b18cedceca73
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY13649035-a498-4e31-a7ea-8b18cedceca73
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY13649035-a498-4e31-a7ea-8b18cedceca73
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY13649035-a498-4e31-a7ea-8b18cedceca73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-634-064670806340610 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK10 blister pack2024-06-14NoNoCurrent
46708-634-604670806346060 CAPSULE in 1 BOTTLE (46708-634-60) 60 capsule2024-06-14NoNoCurrent