FDA.reportPublic FDA data

RANITIDINE

Product NDC
64980-636
11-digit product format
649800636
Labeler code
64980
Product ID
64980-636_b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANITIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211289
Marketing category
ANDA
Marketing start
2025-12-06
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
Rxcui198191, 198193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
64980-636-03RANITIDINE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-636-03EA - Each64980-636c4a09e1f-25c9-4548-9961-a5a3d16a343412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN0fba6615-37c2-4ba6-b6e5-09599369a5bc1
198193ranitidine 300 MG Oral TabletPSN0fba6615-37c2-4ba6-b6e5-09599369a5bc1
198191ranitidine 150 MG Oral TabletSCD0fba6615-37c2-4ba6-b6e5-09599369a5bc1
198193ranitidine 300 MG Oral TabletSCD0fba6615-37c2-4ba6-b6e5-09599369a5bc1
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY0fba6615-37c2-4ba6-b6e5-09599369a5bc1
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY0fba6615-37c2-4ba6-b6e5-09599369a5bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-636-036498006360330 TABLET in 1 BOTTLE (64980-636-03) 30 tablet2025-12-06NoNoCurrent