FDA.reportPublic FDA data

Ranitidine Hydrochloride

Product NDC
55111-130
11-digit product format
551110130
Labeler code
55111
Product ID
55111-130_9741e6f4-a2dc-7543-1138-da97eafe11bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA075742
Marketing category
ANDA
Marketing start
2001-04-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranitidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBK76465IHM
Rxcui198190, 198192

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
55111-130-01Ranitidine Hydrochloride100 in 1 BOTTLECAPSULE1003
55111-130-30Ranitidine Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-130-01EA - Each55111-130055f605f-ec4f-4896-9aad-315d769dc1eb12012-07-24
55111-130-30EA - Each55111-1303d42cca5-bb5f-4134-9202-24b49ab54de712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHMRANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
ranitidineACTIVE MOIETY884KT10YB7RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTRANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
gelatinINACTIVE INGREDIENT2G86QN327LRANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
magnesium stearateINACTIVE INGREDIENT70097M6I30RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-130RANITIDINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]3Current NDC, Legacy NDC, 2 package rows20181128_7bf94bf7-fa11-70be-9f65-fe26a3db5a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198190ranitidine 150 MG Oral CapsuleSCD7bf94bf7-fa11-70be-9f65-fe26a3db5a633
198192ranitidine 300 MG Oral CapsuleSCD7bf94bf7-fa11-70be-9f65-fe26a3db5a633
198190ranitidine 150 MG (ranitidine HCl 168 MG) Oral CapsuleSY7bf94bf7-fa11-70be-9f65-fe26a3db5a633
198192ranitidine 300 MG (ranitidine HCl 336 MG) Oral CapsuleSY7bf94bf7-fa11-70be-9f65-fe26a3db5a633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-130-0155111013001100 CAPSULE in 1 BOTTLE (55111-130-01) 100 capsule2001-04-010000-00-00NoNoCurrent
55111-130-305511101303030 CAPSULE in 1 BOTTLE (55111-130-30) 30 capsule2001-04-010000-00-00NoNoCurrent