CIMETIDINE HYDROCHLORIDE

Product NDC
68999-809
11-digit product format
689990809
Labeler code
68999
Product ID
68999-809_42c607ee-eb27-a72c-e063-6394a90a653c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
68999-809-05CIMETIDINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION51
68999-809-24CIMETIDINE HYDROCHLORIDE10 in 1 TRAYSOLUTION101
68999-809-24CIMETIDINE HYDROCHLORIDE2 in 1 BOXSOLUTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212787cimetidine HCl 300 MG in 5 mL Oral SolutionPSNe40bb1f6-338a-42e7-9217-8c32d14ccfd31
212787cimetidine 60 MG/ML Oral SolutionSCDe40bb1f6-338a-42e7-9217-8c32d14ccfd31
212787cimetidine 300 MG per 5 ML Oral SolutionSYe40bb1f6-338a-42e7-9217-8c32d14ccfd31
212787cimetidine 400 MG per 6.7 ML Oral SolutionSYe40bb1f6-338a-42e7-9217-8c32d14ccfd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-809-05689990809055 mL in 1 CUP5 mlHistorical
68999-809-24689990809242 TRAY in 1 BOX (68999-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05) 2 tray2025-10-23NoNoHistorical