Home NDC 52015-700 DIFICID
Product NDC 52015-700
11-digit product format 520150700
Labeler code 52015
Product ID 52015-700_21c95e9f-0a3d-4fb8-90b5-934bad817d00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FIDAXOMICIN
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA213138
Marketing category NDA
Marketing start 2020-02-18
Substance FIDAXOMICIN
Active strength 200 mg/5mL
Pharmacologic classes Macrolide Antibacterial [EPC], Macrolides [CS]
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 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.
Additional Listing Data#
Finished product Yes
Brand name base DIFICID
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FIDAXOMICIN 200 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z5N076G8YQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111106 Internal RxNorm lookup 1111110 Internal RxNorm lookup 2279843 Internal RxNorm lookup 2279847 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 52015-700-21 DIFICID 150 mL in 1 BOTTLE, GLASS GRANULE, FOR SUSPENSION 150 21 52015-700-22 DIFICID 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 21 52015-700-23 DIFICID 1 in 1 POUCH GRANULE, FOR SUSPENSION 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 52015-700 DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] 20 Current NDC, Legacy NDC, 3 package rows 20241030_dd966338-c820-4270-b704-09ef75fa3ceb.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.
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 52015-700-21 52015070021 150 mL in 1 BOTTLE, GLASS 150 ml Historical 52015-700-22 52015070022 1 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21) 1 pouch 2020-02-18 0000-00-00 No No Current 52015-700-23 52015070023 1 in 1 POUCH Historical