Cimetidine

Product NDC
0121-0649
11-digit product format
001210649
Labeler code
0121
Product ID
0121-0649_e16a0b54-26b1-2426-e053-2995a90ac0be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA074553
Marketing category
ANDA
Marketing start
2021-02-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0649-05ML - Milliliter0121-064966292a4b-01c2-4dc7-9489-86931117dd7112021-06-02
0121-0649-08ML - Milliliter0121-06490836062c-126a-4a8e-8f62-7c42edc4249e12021-04-08
0121-0649-40ML - Milliliter0121-064914cc5ee4-266c-41d3-a6af-857b0c836dae12021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0649-0800121064908237 mL in 1 BOTTLE (0121-0649-08) 237 ml2021-02-120000-00-00NoNoCurrent
0121-0649-40001210649404 TRAY in 1 CASE (0121-0649-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0649-05) 4 tray2021-03-260000-00-00NoNoCurrent