Home Applications 213138 Application 213138
Type NDA
Sponsor CUBIST PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIFICID FIDAXOMICIN FOR SUSPENSION;ORAL 40MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213138-001 DIFICID FIDAXOMICIN 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213138-001 7906489 2027-03-04 U-2741 2020-02-21 N213138-001 7378508 2027-07-31 Drug substance, Drug product 2020-02-21 N213138-001 7863249 2027-07-31 Drug product 2020-02-21 N213138-001 8859510 2027-07-31 U-2741 2020-02-21 N213138-001 7906489*PED 2027-09-04 Pediatric extension N213138-001 7378508*PED 2028-01-31 Pediatric extension N213138-001 7863249*PED 2028-01-31 Pediatric extension N213138-001 8859510*PED 2028-01-31 Pediatric extension N213138-001 9808530 2034-05-28 Drug product 2020-02-21 N213138-001 9808530*PED 2034-11-28 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213138-001 ODE-367 2027-01-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213138-001 DIFICID 40MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-01-24 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 12 · 441 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213138-001 7906489 2027-03-04 U-2741 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 7378508 2027-07-31 Drug substance, Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 7863249 2027-07-31 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 8859510 2027-07-31 U-2741 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 7906489*PED 2027-09-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 7378508*PED 2028-01-31 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 7863249*PED 2028-01-31 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 8859510*PED 2028-01-31 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 9808530 2034-05-28 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213138-001 9808530*PED 2034-11-28 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213138-001 7906489 2027-03-04 U-2741 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 7378508 2027-07-31 Drug substance, Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 7863249 2027-07-31 Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 8859510 2027-07-31 U-2741 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 7906489*PED 2027-09-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 7378508*PED 2028-01-31 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 7863249*PED 2028-01-31 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 8859510*PED 2028-01-31 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 9808530 2034-05-28 Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213138-001 9808530*PED 2034-11-28 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213138-001 7906489 2027-03-04 U-2741 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 7378508 2027-07-31 Drug substance, Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 7863249 2027-07-31 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 8859510 2027-07-31 U-2741 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 7906489*PED 2027-09-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 7378508*PED 2028-01-31 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 7863249*PED 2028-01-31 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 8859510*PED 2028-01-31 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 9808530 2034-05-28 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213138-001 9808530*PED 2034-11-28 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7906489 2027-03-04 U-2741 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7378508 2027-07-31 Drug substance, Drug product 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7863249 2027-07-31 Drug product 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 8859510 2027-07-31 U-2741 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7906489*PED 2027-09-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7378508*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 7863249*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 8859510*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 9808530 2034-05-28 Drug product 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213138-001 9808530*PED 2034-11-28 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme Corp. NDA Current 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme Corp. NDA Current 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme LLC NDA Current 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme LLC NDA Current 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme Corp. NDA Current 52015-700 DIFICID FIDAXOMICIN Merck Sharp & Dohme Corp. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 63569 ORIG 2020-06-15 63361 SUPPL 2020-06-01 63348 SUPPL 2020-05-29 61697 ORIG 2020-01-27 61695 ORIG 2020-01-27 62998 ORIG 1900-01-01