FDA.reportPublic FDA data

Ranitidine

Product NDC
27241-109
11-digit product format
272410109
Labeler code
27241
Product ID
27241-109_d7fd99da-f17a-4124-9014-70bbe43d78f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA209859
Marketing category
ANDA
Marketing start
2018-09-27
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE150 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
27241-109-06Ranitidine60 in 1 BOTTLECAPSULE604
27241-109-50Ranitidine500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-109-06EA - Each27241-1095e77192c-34e7-42a6-b8fb-5af4c6a41f5212018-12-13
27241-109-50EA - Each27241-1094b93c9c1-9f9e-4ea3-8ff7-c7d35a21ccc112018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-109RANITIDINE CAPSULE [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 2 package rows20211124_fb67e8c7-b817-4253-a1a1-5ecdcee694cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198190ranitidine 150 MG Oral CapsuleSCDfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198192ranitidine 300 MG Oral CapsuleSCDfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198190ranitidine 150 MG (ranitidine HCl 168 MG) Oral CapsuleSYfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198192ranitidine 300 MG (ranitidine HCl 336 MG) Oral CapsuleSYfb67e8c7-b817-4253-a1a1-5ecdcee694cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-109-062724101090660 CAPSULE in 1 BOTTLE (27241-109-06) 60 capsule2018-09-270000-00-00NoNoCurrent
27241-109-5027241010950500 CAPSULE in 1 BOTTLE (27241-109-50) 500 capsule2018-09-270000-00-00NoNoCurrent