Home NDC 0597-0440 Pradaxa
Product NDC 0597-0440
11-digit product format 005970440
Labeler code 0597
Product ID 0597-0440_56b1a7c2-0afd-40c6-bda5-563e234a9f28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dabigatran etexilate
Dosage form PELLET
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA214358
Marketing category NDA
Marketing start 2022-03-16
Substance DABIGATRAN ETEXILATE MESYLATE
Active strength 50 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214358-001 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 N214358-002 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 N214358-003 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 N214358-004 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 N214358-005 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 N214358-006 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214358-001 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-001 7932273*PED 2026-03-07 Pediatric extension N214358-002 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-002 7932273*PED 2026-03-07 Pediatric extension N214358-003 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-003 7932273*PED 2026-03-07 Pediatric extension N214358-004 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-004 7932273*PED 2026-03-07 Pediatric extension N214358-005 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-005 7932273*PED 2026-03-07 Pediatric extension N214358-006 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 N214358-006 7932273*PED 2026-03-07 Pediatric extension
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 5 · 198 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-005 PRADAXA EQ 110MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-006 PRADAXA EQ 150MG BASE/PACKET PELLETS / ORAL RLD, RS 2021-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-001 PRADAXA EQ 20MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-002 PRADAXA EQ 30MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-003 PRADAXA EQ 40MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-004 PRADAXA EQ 50MG BASE/PACKET PELLETS / ORAL RLD 2021-06-21 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 17 · 660 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214358-001 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-001 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-002 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-002 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-003 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-003 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-004 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-004 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-005 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-005 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-006 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214358-006 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-001 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-001 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-002 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-002 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-003 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-003 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-004 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-004 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-005 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-005 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-006 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214358-006 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214358-001 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-001 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-002 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-002 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-003 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-003 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-004 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-004 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-005 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-005 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-006 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214358-006 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-001 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-001 7932273*PED 2026-03-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-002 7932273 2025-09-07 Drug substance, Drug product 2021-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214358-002 7932273*PED 2026-03-07 Pediatric extension fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 9 · 324 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-001 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-001 PED 2024-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-002 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-002 PED 2024-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-003 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-003 PED 2024-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-004 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-004 PED 2024-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-005 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-005 PED 2024-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-006 NP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214358-006 PED 2024-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-001 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-001 PED 2024-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-002 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-002 PED 2024-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-003 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-003 PED 2024-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-004 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-004 PED 2024-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-005 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-005 PED 2024-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-006 NP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214358-006 PED 2024-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-001 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-001 PED 2024-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-002 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-002 PED 2024-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-003 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-003 PED 2024-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-004 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-004 PED 2024-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-005 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-005 PED 2024-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-006 NP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214358-006 PED 2024-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214358-001 NP 2024-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214358-001 PED 2024-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214358-002 NP 2024-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214358-002 PED 2024-12-21 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Pradaxa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DABIGATRAN ETEXILATE MESYLATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SC7NUW5IIT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2590616 Internal RxNorm lookup 2590619 Internal RxNorm lookup 2590620 Internal RxNorm lookup 2590621 Internal RxNorm lookup 2590623 Internal RxNorm lookup 2590625 Internal RxNorm lookup 2590627 Internal RxNorm lookup 2590629 Internal RxNorm lookup 2590631 Internal RxNorm lookup 2590633 Internal RxNorm lookup 2590635 Internal RxNorm lookup 2590637 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0440-53 Pradaxa 1 in 1 CARTON PELLET 1 7 0597-0440-53 Pradaxa 60 in 1 BAG PELLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0440 PRADAXA (DABIGATRAN ETEXILATE) PELLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20231129_9ac0a64a-8666-45f7-9d4f-40fd894f7e6d.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pradaxa DABIGATRAN ETEXILATE Boehringer Ingelheim Pharmaceuticals, Inc. 9ac0a64a-8666-45f7-9d4f-40fd894f7e6d 2025-06-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214358 application number: NDA214358 ndc (product): 0597-0440
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0440-53 00597044053 1 BAG in 1 CARTON (0597-0440-53) / 60 PELLET in 1 BAG 1 bag 2022-03-16 0000-00-00 No No Current