Home NDC 24338-018 MYHIBBIN
Product NDC 24338-018
11-digit product format 243380018
Labeler code 24338
Product ID 24338-018_4a03cc1d-8a3d-4b41-a8df-2772a513bd61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MYCOPHENOLATE MOFETIL
Dosage form SUSPENSION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA216482
Marketing category NDA
Marketing start 2024-06-10
Substance MYCOPHENOLATE MOFETIL
Active strength 200 mg/mL
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
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 N216482-001 MYHIBBIN MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21
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 2026-10-15 13:18:30 2026-09 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216482-001 MYHIBBIN 200MG/ML SUSPENSION / ORAL RLD, RS 2024-05-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216482-001 12226526 2039-08-16 U-1752 Drug product 2025-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216482-001 12097284 2039-08-16 Drug product 2024-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216482-001 12097285 2039-08-16 U-1752 Drug product 2024-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216482-001 12194143 2039-08-16 U-1752 Drug product 2025-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216482-001 11931455 2039-08-16 U-1752 Drug product 2024-05-15 03ed91905a0d…
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 MYHIBBIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MYCOPHENOLATE MOFETIL 200 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24338-018-01 MYHIBBIN 175 mL in 1 BOTTLE, PLASTIC SUSPENSION 175 5 24338-018-01 MYHIBBIN 1 in 1 CARTON SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-018 MYHIBBIN (MYCOPHENOLATE MOFETIL) SUSPENSION [AZURITY PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240611_d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 24338-018-01 24338001801 1 BOTTLE, PLASTIC in 1 CARTON (24338-018-01) / 175 mL in 1 BOTTLE, PLASTIC 2024-06-10 No No Current