Mesalamine

Product NDC: 60687-650
11-digit product format: 606870650
Labeler code: 60687
Product ID: 60687-650_35a82cc9-c874-4e8d-e063-6294a90a8c69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA214242
Marketing category: ANDA
Marketing start: 2022-09-06
Substance: MESALAMINE
Active strength: .375 g/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Mesalamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	.375 g/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	4Q81I59GXC
Rxcui	825130

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3	Product name	3	20260128
37997c2c-8686-b078-51f1-fb15da0c0a1c	Product name	6	20260127
97851e97-0a12-4d74-aaa4-9583fe070304	Product name	2	20250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49	Product name	5	20250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564	Product name	5	20240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3	Product name	1	20230124
a4dbd90c-f616-c999-40d7-60da88952163	Product name	2	20190802
77831c26-5062-ed63-fc15-a07600377b5b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-650-32	Mesalamine	20 in 1 CARTON	CAPSULE, EXTENDED RELEASE	20		4
60687-650-33	Mesalamine	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-650-32	EA - Each	60687-650	e90b50be-c82e-4251-a3cc-2f1ac8254320	1	2022-09-12
60687-650-33	EA - Each	60687-650	b702f647-6a28-47d9-b057-0b99ecbc6265	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-650	MESALAMINE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3	Current NDC, Legacy NDC, 2 package rows	20241004_e638681d-8fca-4bf8-a1fb-8e52357a64da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
825130	mesalamine 0.375 GM 24HR Extended Release Oral Capsule	PSN	e638681d-8fca-4bf8-a1fb-8e52357a64da	4
825130	24 HR mesalamine 375 MG Extended Release Oral Capsule	SCD	e638681d-8fca-4bf8-a1fb-8e52357a64da	4
825130	mesalamine 375 MG 24 HR Extended Release Oral Capsule	SY	e638681d-8fca-4bf8-a1fb-8e52357a64da	4
825130	mesalazine 375 MG 24 HR Extended Release Oral Capsule	SY	e638681d-8fca-4bf8-a1fb-8e52357a64da	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-650-32	60687065032	20 BLISTER PACK in 1 CARTON (60687-650-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-650-33)	20 blister pack	2022-09-06	0000-00-00	No	No	Current
60687-650-33	60687065033	1 in 1 BLISTER PACK						Historical