FDA.reportPublic FDA data

Cimetidine

Product NDC
50090-0500
11-digit product format
500900500
Labeler code
50090
Product ID
50090-0500_ae5b3c50-f23b-465c-9a57-cbb92ddbd3b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074151
Marketing category
ANDA
Marketing start
2004-02-02
Substance
CIMETIDINE
Active strength
400 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
CIMETIDINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197506, 197507

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0500-02023-02-07C16284748780-1f386c649-e12a-0266-e053-dadaa90a7c1aCimetidine Tablets , USP Rx only
50090-0500-12023-02-07C16284748780-1f386c649-e12a-0266-e053-dadaa90a7c1aCimetidine Tablets , USP Rx only
50090-0500-02023-01-30C16284748780-1f386c649-e12a-0266-e053-dadaa90a7c1aCimetidine Tablets , USP Rx only
50090-0500-12023-01-30C16284748780-1f386c649-e12a-0266-e053-dadaa90a7c1aCimetidine Tablets , USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0500-0Cimetidine30 in 1 BOTTLETABLET, FILM COATED3024
50090-0500-1Cimetidine60 in 1 BOTTLETABLET, FILM COATED6024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0500-0EA - Each50090-05003ff422d8-f165-4bec-8ddb-d8f2281abbe912018-09-05
50090-0500-1EA - Each50090-050014cfe81b-2df9-4c51-85af-b2856ad52ba012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0500CIMETIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 2 package rows20241109_cf1626a1-ccf6-4759-b2ab-22c7f3873d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSNcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197507cimetidine 400 MG Oral TabletPSNcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197506cimetidine 300 MG Oral TabletSCDcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197507cimetidine 400 MG Oral TabletSCDcf1626a1-ccf6-4759-b2ab-22c7f3873d8424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0500-05009005000030 TABLET, FILM COATED in 1 BOTTLE (50090-0500-0) 2016-06-290000-00-00NoNoCurrent
50090-0500-15009005000160 TABLET, FILM COATED in 1 BOTTLE (50090-0500-1) 2016-07-260000-00-00NoNoCurrent