FDA.reportPublic FDA data

KAPSPARGO

Product NDC
10631-010
11-digit product format
106310010
Labeler code
10631
Product ID
10631-010_b982da20-735c-49d8-ad1f-6a831194db87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA210428
Marketing category
NDA
Marketing start
2018-03-15
Substance
METOPROLOL SUCCINATE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui1999031, 1999033, 1999035, 1999037, 2047766, 2047769, 2047772, 2047775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10631-010-30KAPSPARGO30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-010-30EA - Each10631-010f0e727bb-c985-4587-be98-f0425701db3412018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10631-010KAPSPARGO (METOPROLOL SUCCINATE) CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 1 package rows20230420_9cfa55b4-15c6-40f7-b6e5-41096ee51bfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047766KAPSPARGO Sprinkle 100 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
2047769KAPSPARGO Sprinkle 200 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
2047772KAPSPARGO Sprinkle 25 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
2047775KAPSPARGO Sprinkle 50 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999031metoprolol succinate 100 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999033metoprolol succinate 200 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999035metoprolol succinate 25 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999037metoprolol succinate 50 MG 24HR Extended Release Oral CapsulePSN9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204776624 HR metoprolol succinate 100 MG Extended Release Oral Capsule [Kapspargo]SBD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204776924 HR metoprolol succinate 200 MG Extended Release Oral Capsule [Kapspargo]SBD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204777224 HR metoprolol succinate 25 MG Extended Release Oral Capsule [Kapspargo]SBD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204777524 HR metoprolol succinate 50 MG Extended Release Oral Capsule [Kapspargo]SBD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
199903124 HR metoprolol succinate 100 MG Extended Release Oral CapsuleSCD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
199903324 HR metoprolol succinate 200 MG Extended Release Oral CapsuleSCD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
199903524 HR metoprolol succinate 25 MG Extended Release Oral CapsuleSCD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
199903724 HR metoprolol succinate 50 MG Extended Release Oral CapsuleSCD9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204776624 HR Kapspargo 100 MG Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204776924 HR Kapspargo 200 MG Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204777224 HR Kapspargo 25 MG Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
204777524 HR Kapspargo 50 MG Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999031metoprolol succinate 100 MG 24 HR Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999033metoprolol succinate 200 MG 24 HR Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999035metoprolol succinate 25 MG 24 HR Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12
1999037metoprolol succinate 50 MG 24 HR Extended Release Oral CapsuleSY9cfa55b4-15c6-40f7-b6e5-41096ee51bfc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10631-010-301063100103030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-010-30) 2018-03-150000-00-00NoNoCurrent