Mesalamine

Product NDC
63629-8679
11-digit product format
636298679
Labeler code
63629
Product ID
63629-8679_3735ed2d-e468-4890-813a-991f3aa5fd48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
KIT
Labeler
Bryant Ranch Prepack
Application
ANDA076751
Marketing category
ANDA
Marketing start
2018-08-02
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui238151

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-098-46Mesalamine60 mL in 1 BOTTLEENEMA420 mL4 g in 60mL106
63629-8679-1Mesalamine4 in 1 KITKIT4106
63629-8679-1Mesalamine1 in 1 CARTONKIT1106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8679-1EA - Each63629-86795f4df694-5746-4af9-bebc-c225beb38ae212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8679MESALAMINE KIT [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20241109_1e561474-6169-410e-b83d-7e96d375831d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238151mesalamine 4 GM in 60 mL EnemaPSN1e561474-6169-410e-b83d-7e96d375831d106
238151mesalamine 66.7 MG/ML EnemaSCD1e561474-6169-410e-b83d-7e96d375831d106
238151mesalamine 4 GM per 60 ML EnemaSY1e561474-6169-410e-b83d-7e96d375831d106
238151mesalazine 66.7 MG/ML EnemaSY1e561474-6169-410e-b83d-7e96d375831d106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-098-464580200984660 mL in 1 BOTTLE60 mlHistorical
63629-8679-1636298679014 CARTON in 1 KIT (63629-8679-1) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET4 carton2018-08-020000-00-00NoNoCurrent