MYHIBBIN

Product NDC
24338-018
11-digit product format
243380018
Labeler code
24338
Product ID
24338-018_d90d3f5a-98a2-4e50-8bb1-db76875c9b8c
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

Additional Listing Data#

Finished product
Yes
Brand name base
MYHIBBIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui311880, 2684851

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-018-01MYHIBBIN175 mL in 1 BOTTLE, PLASTICSUSPENSION1755
24338-018-01MYHIBBIN1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-018-01ML - Milliliter24338-018fdf10259-0f7f-402a-b0a8-12cf45e714f412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-018MYHIBBIN (MYCOPHENOLATE MOFETIL) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240611_d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311880mycophenolate mofetil 200 MG in 1 mL Oral SuspensionPSNd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
2684851Myhibbin 200 MG in 1 mL Oral SuspensionPSNd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
2684851mycophenolate mofetil 200 MG/ML Oral Suspension [Myhibbin]SBDd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
311880mycophenolate mofetil 200 MG/ML Oral SuspensionSCDd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
311880mycophenolate mofetil 200 MG per 1 ML Oral SuspensionSYd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
2684851Myhibbin 200 MG per 1 ML Oral SuspensionSYd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95
2684851Myhibbin 200 MG/ML Oral SuspensionSYd9af72d6-7b3e-4c08-94b9-1d8b499cb7f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24338-018-01243380018011 BOTTLE, PLASTIC in 1 CARTON (24338-018-01) / 175 mL in 1 BOTTLE, PLASTIC2024-06-10NoNoHistorical