DABIGATRAN

Product NDC
72205-203
11-digit product format
722050203
Labeler code
72205
Product ID
72205-203_50fb8204-a087-4f97-ab57-85773b8c0065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DABIGATRAN ETEXILATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213879
Marketing category
ANDA
Marketing start
2024-08-12
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
2027-12-31
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
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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213879-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213879-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2024-05-221e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213879-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2024-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213879-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213879-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213879-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213879-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213879-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213879-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213879-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213879-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213879-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213879-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213879-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213879-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213879-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213879-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213879-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213879-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213879-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213879-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213879-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213879-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213879-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213879-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213879-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213879-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213879-002AB11e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213879-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
DABIGATRAN
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
6f79088b-b353-485a-9df4-6f5088f5bd0fAvailable 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
72205-203-34DABIGATRAN6 in 1 CARTONCAPSULE64
72205-203-34DABIGATRAN10 in 1 BLISTER PACKCAPSULE104
72205-203-60DABIGATRAN60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-203-60EA - Each72205-2031167c2ac-0331-4ab3-b125-4728f01ddf2c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-203DABIGATRAN (DABIGATRAN ETEXILATE) CAPSULE [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, 3 package rows20241022_6f79088b-b353-485a-9df4-6f5088f5bd0f.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 · 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
ndc (product): 72205-203
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG Oral CapsulePSN6f79088b-b353-485a-9df4-6f5088f5bd0f4
1723476dabigatran etexilate 110 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG Oral CapsuleSCD6f79088b-b353-485a-9df4-6f5088f5bd0f4
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY6f79088b-b353-485a-9df4-6f5088f5bd0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-203-34722050203346 BLISTER PACK in 1 CARTON (72205-203-34) / 10 CAPSULE in 1 BLISTER PACK6 blister pack2024-10-01NoNoCurrent
72205-203-607220502036060 CAPSULE in 1 BOTTLE (72205-203-60) 60 capsule2024-08-14NoNoCurrent