Home NDC 52015-080 Dificid
Product NDC 52015-080
11-digit product format 520150080
Labeler code 52015
Product ID 52015-080_22ef2f1a-cf0e-4733-b749-2a1adfb5c917
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fidaxomicin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA201699
Marketing category NDA
Marketing start 2011-05-27
Substance FIDAXOMICIN
Active strength 200 mg/1
Pharmacologic classes Macrolide Antibacterial [EPC], Macrolides [CS]
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 44 .
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 N201699-001 DIFICID FIDAXOMICIN 200MG TABLET / ORAL AB RLD, RS 2011-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201699-001 AB
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 N201699-001 7906489 2027-03-04 U-2741 2011-08-29 N201699-001 7906489 2027-03-04 U-319 2011-08-29 N201699-001 7378508 2027-07-31 Drug substance, Drug product 2011-08-29 N201699-001 7863249 2027-07-31 Drug substance, Drug product 2011-08-29 N201699-001 8859510 2027-07-31 U-2741 2014-11-05 N201699-001 8859510 2027-07-31 U-319 2014-11-05 N201699-001 7906489*PED 2027-09-04 Pediatric extension N201699-001 7378508*PED 2028-01-31 Pediatric extension N201699-001 7863249*PED 2028-01-31 Pediatric extension N201699-001 8859510*PED 2028-01-31 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 N201699-001 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.
Product history page 1 of 2 · 44 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 2026-10-15 13:18:30 2026-09 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201699-001 DIFICID 200MG TABLET / ORAL AB RLD, RS 2011-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201699-001 DIFICID 200MG TABLET / ORAL RLD, RS 2011-05-27 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 2 of 12 · 471 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7906489 2027-03-04 U-319 2011-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7906489 2027-03-04 U-2741 2011-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7378508 2027-07-31 Drug substance, Drug product 2011-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7863249 2027-07-31 Drug substance, Drug product 2011-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 8859510 2027-07-31 U-319 2014-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 8859510 2027-07-31 U-2741 2014-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7906489*PED 2027-09-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7378508*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 7863249*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201699-001 8859510*PED 2028-01-31 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201699-001 7906489 2027-03-04 U-319 2011-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7906489 2027-03-04 U-2741 2011-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7378508 2027-07-31 Drug substance, Drug product 2011-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7863249 2027-07-31 Drug substance, Drug product 2011-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 8859510 2027-07-31 U-319 2014-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 8859510 2027-07-31 U-2741 2014-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7906489*PED 2027-09-04 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7378508*PED 2028-01-31 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 7863249*PED 2028-01-31 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201699-001 8859510*PED 2028-01-31 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7906489 2027-03-04 U-319 2011-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7906489 2027-03-04 U-2741 2011-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7378508 2027-07-31 Drug substance, Drug product 2011-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7863249 2027-07-31 Drug substance, Drug product 2011-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 8859510 2027-07-31 U-319 2014-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 8859510 2027-07-31 U-2741 2014-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7906489*PED 2027-09-04 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7378508*PED 2028-01-31 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 7863249*PED 2028-01-31 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201699-001 8859510*PED 2028-01-31 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7906489 2027-03-04 U-319 2011-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7906489 2027-03-04 U-2741 2011-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7378508 2027-07-31 Drug substance, Drug product 2011-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7863249 2027-07-31 Drug substance, Drug product 2011-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 8859510 2027-07-31 U-319 2014-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 8859510 2027-07-31 U-2741 2014-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7906489*PED 2027-09-04 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7378508*PED 2028-01-31 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 7863249*PED 2028-01-31 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201699-001 8859510*PED 2028-01-31 Pediatric extension b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 75 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dificid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FIDAXOMICIN 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52015-080-01 Dificid 20 in 1 BOTTLE TABLET, FILM COATED 20 21 52015-080-01 Dificid 1 in 1 CARTON TABLET, FILM COATED 1 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FIDAXOMICIN ACTIVE INGREDIENT Z5N076G8YQ DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 FIDAXOMICIN ACTIVE MOIETY Z5N076G8YQ DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52015-080 DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] 20 Current NDC, Legacy NDC, 2 package rows 20241030_dd966338-c820-4270-b704-09ef75fa3ceb.zip
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 52015-080-01 52015008001 1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2011-05-27 0000-00-00 No No Current