CIMETIDINE

Product NDC
59651-824
11-digit product format
596510824
Labeler code
59651
Product ID
59651-824_ebd53065-c080-4045-a398-64d3f3b1460f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218997
Marketing category
ANDA
Marketing start
2024-11-12
Substance
CIMETIDINE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197505, 197506, 197507, 197508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-824-01CIMETIDINE100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-824-01EA - Each59651-824585669b0-d4e0-43e3-a962-b3c7d0c94d0c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-824CIMETIDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20241122_ebd53065-c080-4045-a398-64d3f3b1460f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSNebd53065-c080-4045-a398-64d3f3b1460f1
197506cimetidine 300 MG Oral TabletPSNebd53065-c080-4045-a398-64d3f3b1460f1
197507cimetidine 400 MG Oral TabletPSNebd53065-c080-4045-a398-64d3f3b1460f1
197508cimetidine 800 MG Oral TabletPSNebd53065-c080-4045-a398-64d3f3b1460f1
197505cimetidine 200 MG Oral TabletSCDebd53065-c080-4045-a398-64d3f3b1460f1
197506cimetidine 300 MG Oral TabletSCDebd53065-c080-4045-a398-64d3f3b1460f1
197507cimetidine 400 MG Oral TabletSCDebd53065-c080-4045-a398-64d3f3b1460f1
197508cimetidine 800 MG Oral TabletSCDebd53065-c080-4045-a398-64d3f3b1460f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-824-0159651082401100 TABLET, FILM COATED in 1 BOTTLE (59651-824-01) 2024-11-12NoNoCurrent
59651-824-415965108244140000 TABLET, FILM COATED in 1 BAG (59651-824-41)12-NOV-24Current