FDA.reportPublic FDA data

Ranitidine

Product NDC
62207-774
11-digit product format
622070774
Labeler code
62207
Product ID
62207-774_44f2b222-ae43-eef4-e063-6394a90ab2b6
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA210243
Marketing category
ANDA
Marketing start
2019-06-26
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
Brand name suffix
cool mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBK76465IHM
Rxcui198191

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
62207-774-36Ranitidinecool mint5 in 1 CARTONTABLET511
62207-774-36Ranitidinecool mint10000 in 1 BAGTABLET1000011
62207-774-41Ranitidinecool mint1 in 1 CARTONTABLET111
62207-774-41Ranitidinecool mint24 in 1 BOTTLETABLET2411
62207-774-47Ranitidinecool mint1 in 1 CARTONTABLET111
62207-774-47Ranitidinecool mint500 in 1 BOTTLETABLET50011
62207-774-58Ranitidinecool mint10 in 1 BLISTER PACKTABLET1011
62207-774-58Ranitidinecool mint2 in 1 CARTONTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-774RANITIDINE COOL MINT (RANITIDINE) TABLET RANITIDINE TABLET [GRANULES INDIA LTD]10Current NDC, Legacy NDC, 8 package rows20241109_aab81d9f-397d-49fb-8083-77a1872cc71f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNaab81d9f-397d-49fb-8083-77a1872cc71f11
198191ranitidine 150 MG Oral TabletSCDaab81d9f-397d-49fb-8083-77a1872cc71f11
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYaab81d9f-397d-49fb-8083-77a1872cc71f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-774-36622070774365 BAG in 1 CARTON (62207-774-36) / 10000 TABLET in 1 BAG5 bag2019-06-260000-00-00NoNoCurrent
62207-774-41622070774411 BOTTLE in 1 CARTON (62207-774-41) / 24 TABLET in 1 BOTTLE1 bottle2019-06-260000-00-00NoNoCurrent
62207-774-47622070774471 BOTTLE in 1 CARTON (62207-774-47) / 500 TABLET in 1 BOTTLE1 bottle2019-06-260000-00-00NoNoCurrent
62207-774-58622070774582 BLISTER PACK in 1 CARTON (62207-774-58) / 10 TABLET in 1 BLISTER PACK2 blister pack2019-06-260000-00-00NoNoCurrent