Mesalamine

Product NDC: 60687-397
11-digit product format: 606870397
Labeler code: 60687
Product ID: 60687-397_278689c8-9371-59ed-e063-6294a90a7bda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA091640
Marketing category: ANDA
Marketing start: 2018-10-11
Substance: MESALAMINE
Active strength: 1.2 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	1.2 g/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	4Q81I59GXC
Rxcui	686429

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
60687-397-25	Mesalamine	30 in 1 BOX, UNIT-DOSE	TABLET, DELAYED RELEASE	30		7
60687-397-95	Mesalamine	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-397-25	EA - Each	60687-397	248f3b9d-01e0-42c8-94d9-242e85561031	1	2018-11-06
60687-397-95	EA - Each	60687-397	6238c9c8-6b7b-48a2-a746-ec7ad96b0f0c	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-397	MESALAMINE TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7	Current NDC, Legacy NDC, 2 package rows	20241124_77140634-9f32-40ca-8c83-9fcc3e373c16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	77140634-9f32-40ca-8c83-9fcc3e373c16	7
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	77140634-9f32-40ca-8c83-9fcc3e373c16	7
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	SY	77140634-9f32-40ca-8c83-9fcc3e373c16	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-397-25	60687039725	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)	30 blister pack	2018-10-11	0000-00-00	No	No	Current
60687-397-95	60687039795	1 in 1 BLISTER PACK						Historical