Ranitidine Hydrochloride

Product NDC
21695-338
11-digit product format
216950338
Labeler code
21695
Product ID
21695-338_b6c0ff30-03f5-4c1b-9077-f0918cf40a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074655
Marketing category
ANDA
Marketing start
1997-10-22
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-338-302019-09-24C16284748780-1934fe258-4944-48b1-e053-8cdaa90a720aRanitidine Tablets, USP and Ranitidine Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-338-30Ranitidine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-338-30EA - Each21695-33814888d4e-9658-4fd5-b5b0-de6737f88c9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-338RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101201_b6c0ff30-03f5-4c1b-9077-f0918cf40a91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198190ranitidine 150 MG Oral CapsuleSCDb6c0ff30-03f5-4c1b-9077-f0918cf40a911
198192ranitidine 300 MG Oral CapsuleSCDb6c0ff30-03f5-4c1b-9077-f0918cf40a911
198190ranitidine 150 MG (ranitidine HCl 168 MG) Oral CapsuleSYb6c0ff30-03f5-4c1b-9077-f0918cf40a911
198192ranitidine 300 MG (ranitidine HCl 336 MG) Oral CapsuleSYb6c0ff30-03f5-4c1b-9077-f0918cf40a911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-338-302169503383030 in 1 BOTTLEHistorical