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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date	Source SHA-256
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 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`d06236e962d9…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9242ECW6R0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311880	Internal RxNorm lookup
2684851	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04b26d3d-97dc-48db-824b-10b299945382	Product name	8	20250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4b	Product name	1	20250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3	Product name	9	20210224

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24338-018-01	ML - Milliliter	24338-018	fdf10259-0f7f-402a-b0a8-12cf45e714f4	1	2024-06-10

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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYHIBBIN	MYCOPHENOLATE MOFETIL	Azurity Pharmaceuticals, Inc.	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216482 application number: NDA216482 ndc (product): 24338-018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9242ECW6R0	MYCOPHENOLATE MOFETIL	128794-94-5	MYCOPHENOLATE MOFETIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311880	mycophenolate mofetil 200 MG in 1 mL Oral Suspension	PSN	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
2684851	Myhibbin 200 MG in 1 mL Oral Suspension	PSN	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
2684851	mycophenolate mofetil 200 MG/ML Oral Suspension [Myhibbin]	SBD	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
311880	mycophenolate mofetil 200 MG/ML Oral Suspension	SCD	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
311880	mycophenolate mofetil 200 MG per 1 ML Oral Suspension	SY	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
2684851	Myhibbin 200 MG per 1 ML Oral Suspension	SY	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5
2684851	Myhibbin 200 MG/ML Oral Suspension	SY	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	5

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