Ranitidine

Product NDC
17856-0664
11-digit product format
178560664
Labeler code
17856
Product ID
17856-0664_9d0f743b-84a7-4258-93d6-4ab6b573e400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA078312
Marketing category
ANDA
Marketing start
2010-03-12
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0664-2Ranitidine10 mL in 1 CUPSOLUTION102
17856-0664-4Ranitidine1 mL in 1 SYRINGESOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0664-4ML - Milliliter17856-0664c6ff3b6d-2ae8-4c19-b8dd-83a1357f9b6512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SORBITOLINACTIVE INGREDIENT506T60A25RRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0664RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20140515_804ba82f-aaf6-46ec-8765-341c5ee2942a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD804ba82f-aaf6-46ec-8765-341c5ee2942a2
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY804ba82f-aaf6-46ec-8765-341c5ee2942a2
705610ranitidine 75 MG per 5 ML SyrupSY804ba82f-aaf6-46ec-8765-341c5ee2942a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0664-21785606640210 mL in 1 CUP10 mlHistorical
17856-0664-4178560664041 mL in 1 SYRINGE1 mlHistorical