Ranitidine

Product NDC
50383-051
11-digit product format
503830051
Labeler code
50383
Product ID
50383-051_4029ac91-63f2-4319-bd98-c80865fd4615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
SOLUTION
Route
ORAL
Labeler
Hi-Tech Pharmacal Co., Inc.
Application
ANDA091078
Marketing category
ANDA
Marketing start
2011-03-22
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-051-10ML - Milliliter50383-051ae30b014-0ed7-4f6d-a34f-65e0a9da85a912013-03-03
50383-051-11ML - Milliliter50383-05182958731-7462-4e49-b1d7-9b73952bf55112014-02-04
50383-051-12ML - Milliliter50383-0514e37348a-172c-478d-9ad4-5e595ffad55112014-02-04
50383-051-16ML - Milliliter50383-05105549ae0-9335-483f-b5b4-15a2dc5a676a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RRANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]3