FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
70436-166
11-digit product format
704360166
Labeler code
70436
Product ID
70436-166_18a2b62c-c586-60fd-e063-6294a90a2a02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA213854
Marketing category
ANDA
Marketing start
2021-04-29
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
Metoprolol succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412, 866419, 866427, 866436

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-166-01Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
70436-166-02Metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
70436-166-03Metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-166-01EA - Each70436-16668ddb2e0-53b1-4134-b4a2-f99cbe00781e12021-06-02
70436-166-02EA - Each70436-166b49e7cd7-964f-4f35-ab11-8011fd925dfd12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-166METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 3 package rows20240518_c00f99e2-7a88-6f9b-e053-2995a90a6ace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN6103540c-93b5-46e8-9ef3-5059fa0335ab103
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD6103540c-93b5-46e8-9ef3-5059fa0335ab103
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY6103540c-93b5-46e8-9ef3-5059fa0335ab103
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY6103540c-93b5-46e8-9ef3-5059fa0335ab103
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYc00f99e2-7a88-6f9b-e053-2995a90a6ace11
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNe780699f-d795-44ce-9828-a0caa6283fb33
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNfa160cd3-4349-8e94-e053-6394a90a58873
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDe780699f-d795-44ce-9828-a0caa6283fb33
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDfa160cd3-4349-8e94-e053-6394a90a58873
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYe780699f-d795-44ce-9828-a0caa6283fb33
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYfa160cd3-4349-8e94-e053-6394a90a58873
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYe780699f-d795-44ce-9828-a0caa6283fb33
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYfa160cd3-4349-8e94-e053-6394a90a58873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-166-0170436016601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-166-01) 2021-04-290000-00-00NoNoCurrent
70436-166-0270436016602500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-166-02) 2021-04-290000-00-00NoNoCurrent
70436-166-03704360166031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-166-03) 2021-04-290000-00-00NoNoCurrent