CIMETIDINE

Product NDC
62135-633
11-digit product format
621350633
Labeler code
62135
Product ID
62135-633_0337689b-c5d5-d881-e063-6394a90aaec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074329
Marketing category
ANDA
Marketing start
1994-05-17
Substance
CIMETIDINE
Active strength
800 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
CIMETIDINE800 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-633-90CIMETIDINE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-633-90EA - Each62135-633050fed10-15aa-436f-9beb-ce7557eab14c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-633CIMETIDINE TABLET, FILM COATED [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230819_01997826-7ca1-473e-bfc9-075b14b58a35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSN01997826-7ca1-473e-bfc9-075b14b58a351
197506cimetidine 300 MG Oral TabletPSN01997826-7ca1-473e-bfc9-075b14b58a351
197507cimetidine 400 MG Oral TabletPSN01997826-7ca1-473e-bfc9-075b14b58a351
197508cimetidine 800 MG Oral TabletPSN01997826-7ca1-473e-bfc9-075b14b58a351
197505cimetidine 200 MG Oral TabletSCD01997826-7ca1-473e-bfc9-075b14b58a351
197506cimetidine 300 MG Oral TabletSCD01997826-7ca1-473e-bfc9-075b14b58a351
197507cimetidine 400 MG Oral TabletSCD01997826-7ca1-473e-bfc9-075b14b58a351
197508cimetidine 800 MG Oral TabletSCD01997826-7ca1-473e-bfc9-075b14b58a351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-633-906213506339090 TABLET, FILM COATED in 1 BOTTLE (62135-633-90) 2023-08-15NoNoHistorical