Atenolol

Product NDC
60760-643
11-digit product format
607600643
Labeler code
60760
Product ID
60760-643_8abceaca-3530-b97a-e053-2a95a90ae2f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA077443
Marketing category
ANDA
Marketing start
2019-01-14
Substance
ATENOLOL
Active strength
50 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

openFDA Listing Details

Product ID
60760-643_8abceaca-3530-b97a-e053-2a95a90ae2f3
SPL ID
8abceaca-3530-b97a-e053-2a95a90ae2f3
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Atenolol
Generic name
Atenolol
Dosage form
TABLET
Route
ORAL
Marketing start
2019-01-14
Marketing category
ANDA
Application number
ANDA077443
Pharmacologic classes
Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
ATENOLOL50 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii50VV3VW0TI
Rxcui197381
Spl Set Id7f8304a4-93de-774f-e053-2a91aa0aa5b5
Manufacturer NameSt. Mary's Medical Park Pharmacy

openFDA Package Details

Package NDCDescriptionMarketing startSample
60760-643-3030 TABLET in 1 BOTTLE, PLASTIC (60760-643-30)2019-01-14No
60760-643-9090 TABLET in 1 BOTTLE, PLASTIC (60760-643-90)2019-06-07No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
50VV3VW0TIATENOLOL29122-68-7ATENOLOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-643-306076006433030 TABLET in 1 BOTTLE, PLASTIC (60760-643-30) 30 tablet2019-01-14NoNoHistorical
60760-643-906076006439090 TABLET in 1 BOTTLE, PLASTIC (60760-643-90) 90 tablet2019-06-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Atenolol Tablets USP 25 mg, 50 mg and 100 mgSt. Mary's Medical Park Pharmacy | Unique Pharmaceutical Laboratories2019-06-07HUMAN PRESCRIPTION DRUG LABEL2