Dabigatran Etexilate

Product NDC
46708-635
11-digit product format
467080635
Labeler code
46708
Product ID
46708-635_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
2024-08-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
2026-08-18 06:07:402026-07A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-06-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-06-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215233-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215233-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215233-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215233-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215233-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215233-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215233-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215233-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215233-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215233-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215233-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215233-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215233-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215233-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215233-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215233-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215233-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215233-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215233-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215233-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215233-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215233-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215233-002AB1301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215233-003AB1a50c72e98297…

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
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
46708-635-06Dabigatran Etexilate10 in 1 CARTONCAPSULE103
46708-635-06Dabigatran Etexilate6 in 1 BLISTER PACKCAPSULE63
46708-635-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-635DABIGATRAN ETEXILATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, 3 package rows20240817_13649035-a498-4e31-a7ea-8b18cedceca7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 46708-635
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Inc.834a3c5f-b723-4bcb-a560-dc305dd0d8292025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215233
application number: ANDA215233

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
46708-635-064670806350610 BLISTER PACK in 1 CARTON (46708-635-06) / 6 CAPSULE in 1 BLISTER PACK10 blister pack2024-08-13NoNoCurrent
46708-635-604670806356060 CAPSULE in 1 BOTTLE (46708-635-60) 60 capsule2024-08-13NoNoCurrent