Ranitidine

Product NDC
0121-4727
11-digit product format
001214727
Labeler code
0121
Product ID
0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANITIDINE
Dosage form
SYRUP
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA077405
Marketing category
ANDA
Marketing start
2010-11-01
Substance
RANITIDINE
Active strength
15 mg/mL
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
Ranitidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii884KT10YB7
Rxcui705610

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4727-10Ranitidine10 in 1 TRAYSYRUP108
0121-4727-10Ranitidine4 in 1 CASESYRUP48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4727-10ML - Milliliter0121-47271a07bbe4-10ce-4619-8608-7b9bdab8e8b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RanitidineACTIVE INGREDIENT884KT10YB7RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
RanitidineACTIVE MOIETY884KT10YB7RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4727RANITIDINE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]8Current NDC, Legacy NDC, 2 package rows20220113_d0da9dd6-c691-4614-99c7-531b0bf34837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCDd0da9dd6-c691-4614-99c7-531b0bf348378
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSYd0da9dd6-c691-4614-99c7-531b0bf348378
705610ranitidine 75 MG per 5 ML SyrupSYd0da9dd6-c691-4614-99c7-531b0bf348378

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4727-10001214727104 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE4 tray2010-11-010000-00-00NoNoCurrent