FDA.reportPublic FDA data

CIMETIDINE HYDROCHLORIDE

Product NDC
62135-809
11-digit product format
621350809
Labeler code
62135
Product ID
62135-809_4a162075-ab76-d848-e063-6294a90aaa9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074251
Marketing category
ANDA
Marketing start
1994-12-22
Substance
CIMETIDINE HYDROCHLORIDE
Active strength
300 mg/5mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE HYDROCHLORIDE300 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWF10491673
Rxcui212787

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
62135-809-05CIMETIDINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION53
62135-809-24CIMETIDINE HYDROCHLORIDE10 in 1 TRAYSOLUTION103
62135-809-24CIMETIDINE HYDROCHLORIDE2 in 1 BOXSOLUTION23
62135-809-37CIMETIDINE HYDROCHLORIDE237 mL in 1 BOTTLESOLUTION2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-809-05ML - Milliliter62135-8093633bfe9-d26d-4e1b-8e2c-b8af6d1b97bf12024-11-05
62135-809-24ML - Milliliter62135-809df6da2b4-c290-4a2b-ba03-552dcd8efb4512024-11-05
62135-809-37ML - Milliliter62135-809ae75c93d-3cee-4aae-b887-1e9f6a2826c712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-809CIMETIDINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 4 package rows20241025_d1d73350-4e7e-428a-90a5-6000fd373a4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212787cimetidine HCl 300 MG in 5 mL Oral SolutionPSNd1d73350-4e7e-428a-90a5-6000fd373a4f3
212787cimetidine 60 MG/ML Oral SolutionSCDd1d73350-4e7e-428a-90a5-6000fd373a4f3
212787cimetidine 300 MG per 5 ML Oral SolutionSYd1d73350-4e7e-428a-90a5-6000fd373a4f3
212787cimetidine 400 MG per 6.7 ML Oral SolutionSYd1d73350-4e7e-428a-90a5-6000fd373a4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-809-05621350809055 mL in 1 CUP5 mlHistorical
62135-809-24621350809242 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05) 2 tray2024-10-22NoNoHistorical
62135-809-3762135080937237 mL in 1 BOTTLE (62135-809-37) 237 ml2024-05-06NoNoHistorical