Rilpivirine

Product NDC
70069-848
11-digit product format
700690848
Labeler code
70069
Product ID
70069-848_8d833cc1-60b6-4e31-aff3-2958b8f93d1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rilpivirine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA218798
Marketing category
ANDA
Marketing start
2026-01-30
Substance
RILPIVIRINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rilpivirine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RILPIVIRINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii212WAX8KDD
Rxcui1102273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
38d19fab-47e8-d825-5329-4948eaa6d686Product name220250124
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
44633898-5724-4273-abcc-3541a1107946Product name120180124
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-848-30Rilpivirine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-848-30EA - Each70069-848d070b5fd-fbda-4d7f-a5ac-d86c98e9e91412026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1102273rilpivirine 25 MG Oral TabletPSNfb109de9-d88d-4405-8dd6-d458cbc387d11
1102273rilpivirine 25 MG Oral TabletSCDfb109de9-d88d-4405-8dd6-d458cbc387d11
1102273rilpivirine 25 MG (rilpivirine hydrochloride 27.5 MG) Oral TabletSYfb109de9-d88d-4405-8dd6-d458cbc387d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70069-848-307006908483030 TABLET, FILM COATED in 1 BOTTLE (70069-848-30) 2026-01-30NoNoHistorical