FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
52817-360
11-digit product format
528170360
Labeler code
52817
Product ID
52817-360_294dc99d-4a6d-22b6-e063-6394a90a06aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA200981
Marketing category
ANDA
Marketing start
2018-12-01
Substance
METOPROLOL TARTRATE
Active strength
25 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 Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514, 866924, 1606347, 1606349

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
52817-360-00Metoprolol Tartrate1000 in 1 BOTTLETABLET, FILM COATED10007
52817-360-10Metoprolol Tartrate100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-360-00EA - Each52817-36055c94e04-8c8d-4995-b3e3-d74c20dd242512019-02-13
52817-360-10EA - Each52817-3607e52773b-e557-4c25-b5a6-32b8c9a5dca312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-360METOPROLOL TARTRATE TABLET, FILM COATED [TRUPHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20241217_52c822f2-4a71-4ab2-a470-58074622846a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN52c822f2-4a71-4ab2-a470-58074622846a7
866924metoprolol tartrate 25 MG Oral TabletPSN52c822f2-4a71-4ab2-a470-58074622846a7
1606347metoprolol tartrate 37.5 MG Oral TabletPSN52c822f2-4a71-4ab2-a470-58074622846a7
866514metoprolol tartrate 50 MG Oral TabletPSN52c822f2-4a71-4ab2-a470-58074622846a7
1606349metoprolol tartrate 75 MG Oral TabletPSN52c822f2-4a71-4ab2-a470-58074622846a7
866511metoprolol tartrate 100 MG Oral TabletSCD52c822f2-4a71-4ab2-a470-58074622846a7
866924metoprolol tartrate 25 MG Oral TabletSCD52c822f2-4a71-4ab2-a470-58074622846a7
1606347metoprolol tartrate 37.5 MG Oral TabletSCD52c822f2-4a71-4ab2-a470-58074622846a7
866514metoprolol tartrate 50 MG Oral TabletSCD52c822f2-4a71-4ab2-a470-58074622846a7
1606349metoprolol tartrate 75 MG Oral TabletSCD52c822f2-4a71-4ab2-a470-58074622846a7
866924metoprolol tartrate 25 MG Oral TabletPSNbac92e34-efe3-4c20-a7bd-6a5382459f9c5
866924metoprolol tartrate 25 MG Oral TabletSCDbac92e34-efe3-4c20-a7bd-6a5382459f9c5
866924metoprolol tartrate 25 MG Oral TabletPSNa2669da1-b712-5fd5-e053-2a95a90a52f33
866924metoprolol tartrate 25 MG Oral TabletSCDa2669da1-b712-5fd5-e053-2a95a90a52f33
866924metoprolol tartrate 25 MG Oral TabletPSNa590edb1-3310-49e3-b3d1-dbbb3f81f1c12
866924metoprolol tartrate 25 MG Oral TabletSCDa590edb1-3310-49e3-b3d1-dbbb3f81f1c12
866924metoprolol tartrate 25 MG Oral TabletPSN83c39ee0-d04e-49a3-a2c9-0774d78aaa3e1
866924metoprolol tartrate 25 MG Oral TabletSCD83c39ee0-d04e-49a3-a2c9-0774d78aaa3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-360-00528170360001000 TABLET, FILM COATED in 1 BOTTLE (52817-360-00) 2018-12-010000-00-00NoNoCurrent
52817-360-1052817036010100 TABLET, FILM COATED in 1 BOTTLE (52817-360-10) 2018-12-010000-00-00YesNoCurrent