Cimetidine

Product NDC
50090-3574
11-digit product format
500903574
Labeler code
50090
Product ID
50090-3574_f09197f2-eaf2-452c-9b3a-58c411fd5e52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074246
Marketing category
ANDA
Marketing start
1994-05-17
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
Rxcui197507

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
50090-3574-02023-02-07C16284748780-1f386c649-a9b4-0266-e053-dadaa90a7c1a28fa98b3-6c78-4b7b-9a37-84c879dbf58a
50090-3574-12023-02-07C16284748780-1f386c649-a9b4-0266-e053-dadaa90a7c1a28fa98b3-6c78-4b7b-9a37-84c879dbf58a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3574-0Cimetidine30 in 1 BOTTLETABLET, FILM COATED307
50090-3574-1Cimetidine60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3574-0EA - Each50090-3574f2753f3f-33a6-49ca-bb7b-f0f73d8536ac12021-10-08
50090-3574-1EA - Each50090-357455639f62-15d0-452d-a9c6-a15824d0699b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3574CIMETIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20250503_28fa98b3-6c78-4b7b-9a37-84c879dbf58a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197507cimetidine 400 MG Oral TabletPSN28fa98b3-6c78-4b7b-9a37-84c879dbf58a7
197507cimetidine 400 MG Oral TabletSCD28fa98b3-6c78-4b7b-9a37-84c879dbf58a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3574-05009035740030 TABLET, FILM COATED in 1 BOTTLE (50090-3574-0) 2018-09-070000-00-00NoNoCurrent
50090-3574-15009035740160 TABLET, FILM COATED in 1 BOTTLE (50090-3574-1) 2019-06-240000-00-00NoNoCurrent