Pindolol

Product NDC
10135-743
11-digit product format
101350743
Labeler code
10135
Product ID
10135-743_4a2bd5cb-bdc6-a71d-e063-6394a90a9a53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pindolol
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA073609
Marketing category
ANDA
Marketing start
2022-06-01
Substance
PINDOLOL
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pindolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PINDOLOL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBJ4HF6IU1D
Rxcui198104, 198105

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
741bb9aa-d388-e012-0ad7-8a85bcbe396eProduct name420200121

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-743-012026-01-29C16284748780-149896155-a672-586f-e063-e6dba90add90PINDOLOL TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-743-01Pindolol100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-743-01EA - Each10135-74374c7273f-3709-41b0-83da-e99b08ad1cc112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-743PINDOLOL TABLET [MARLEX PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20241016_e1049edf-376e-317b-e053-2995a90a2aac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198104pindolol 10 MG Oral TabletPSNe1049edf-376e-317b-e053-2995a90a2aac4
198105pindolol 5 MG Oral TabletPSNe1049edf-376e-317b-e053-2995a90a2aac4
198104pindolol 10 MG Oral TabletSCDe1049edf-376e-317b-e053-2995a90a2aac4
198105pindolol 5 MG Oral TabletSCDe1049edf-376e-317b-e053-2995a90a2aac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-743-0110135074301100 TABLET in 1 BOTTLE (10135-743-01) 100 tablet2022-06-010000-00-00NoNoCurrent