FDA.reportPublic FDA data

Dabigatran Etexilate

Product NDC
31722-621
11-digit product format
317220621
Labeler code
31722
Product ID
31722-621_3b236998-0037-d34f-e063-6294a90a03f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dabigatran Etexilate
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA207961
Marketing category
ANDA
Marketing start
2020-05-06
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
A207961-001DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2020-05-06
A207961-002DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2020-05-06
A207961-003DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207961-001AB
A207961-002AB
A207961-003AB

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 22:54:322026-06A207961-001DABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALAB2020-05-06a50c72e98297…
2026-08-01 22:54:322026-06A207961-002DABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALAB2020-05-06a50c72e98297…
2026-08-01 22:54:322026-06A207961-003DABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALAB2024-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207961-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207961-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A207961-003AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dabigatran EtexilateDABIGATRAN ETEXILATENorthStar RxLLCd5937f27-88c7-4c4a-801e-4c89450089822025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207961
application number: ANDA207961
Dabigatran EtexilateDABIGATRAN ETEXILATECamber Pharmaceuticals, Inc.3c24e235-218b-438e-9456-42c18ff019132025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207961
application number: ANDA207961
ndc (product): 31722-621
Dabigatran EtexilateDABIGATRAN ETEXILATEXLCare Pharmaceuticals, Inc.19b3bfc1-4fcb-4eb9-a611-02c27c05c56e2023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207961
application number: ANDA207961

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
3c24e235-218b-438e-9456-42c18ff01913Available 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
31722-621-32Dabigatran Etexilate6 in 1 BLISTER PACKCAPSULE68
31722-621-32Dabigatran Etexilate10 in 1 CARTONCAPSULE108
31722-621-60Dabigatran Etexilate60 in 1 BOTTLECAPSULE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-621-32EA - Each31722-6217c6e2e29-5756-4b2c-93f2-888a12cab32512025-03-04
31722-621-60EA - Each31722-62101af66c8-cd16-41c3-93f3-32bff3fef06212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-621DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20250213_3c24e235-218b-438e-9456-42c18ff01913.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG Oral CapsulePSN3c24e235-218b-438e-9456-42c18ff019138
1723476dabigatran etexilate 110 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG Oral CapsuleSCD3c24e235-218b-438e-9456-42c18ff019138
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSY3c24e235-218b-438e-9456-42c18ff019138

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-621-323172206213210 BLISTER PACK in 1 CARTON (31722-621-32) / 6 CAPSULE in 1 BLISTER PACK10 blister pack2025-02-03NoNoCurrent
31722-621-603172206216060 CAPSULE in 1 BOTTLE (31722-621-60) 60 capsule2020-05-060000-00-00NoNoCurrent