Ranitidine Hydrochloride

Product NDC
0781-2865
11-digit product format
007812865
Labeler code
0781
Product ID
0781-2865_ed4bcd49-22fa-4c8d-834a-4b6085889b4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
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
No
Listing certified through
2023-12-31
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
0781-2865-05Ranitidine Hydrochloride500 in 1 BOTTLECAPSULE50023
0781-2865-31Ranitidine Hydrochloride30 in 1 BOTTLECAPSULE3023
0781-2865-92Ranitidine Hydrochloride90 in 1 BOTTLECAPSULE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2865-31EA - Each0781-286556bf800b-7acd-4fb2-88a1-d014dc504a1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
AMMONIAINACTIVE INGREDIENT5138Q19F1XRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
GELATININACTIVE INGREDIENT2G86QN327LRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]18
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
0781-2865RANITIDINE HYDROCHLORIDE CAPSULE [SANDOZ INC]23Legacy NDC, 3 package rows20221130_b0af5ca1-9189-4c62-bdf1-f1124ec337e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198190ranitidine 150 MG Oral CapsuleSCDb0af5ca1-9189-4c62-bdf1-f1124ec337e723
198192ranitidine 300 MG Oral CapsuleSCDb0af5ca1-9189-4c62-bdf1-f1124ec337e723
198190ranitidine 150 MG (ranitidine HCl 168 MG) Oral CapsuleSYb0af5ca1-9189-4c62-bdf1-f1124ec337e723
198192ranitidine 300 MG (ranitidine HCl 336 MG) Oral CapsuleSYb0af5ca1-9189-4c62-bdf1-f1124ec337e723
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2865-0500781286505500 CAPSULE in 1 BOTTLE (0781-2865-05) 500 capsule1997-10-220000-00-00NoNoCurrent
0781-2865-310078128653130 CAPSULE in 1 BOTTLE (0781-2865-31) 30 capsule1997-10-220000-00-00NoNoCurrent
0781-2865-920078128659290 CAPSULE in 1 BOTTLE (0781-2865-92) 90 capsule1997-10-220000-00-00NoNoCurrent