FDA.reportPublic FDA data

Vocabria

Product NDC
49702-248
11-digit product format
497020248
Labeler code
49702
Product ID
49702-248_6039b41a-e8a1-4976-bcbc-0fd7b70e423c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cabotegravir sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA212887
Marketing category
NDA
Marketing start
2021-01-21
Substance
CABOTEGRAVIR SODIUM
Active strength
30 mg/1
Pharmacologic classes
HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CABOTEGRAVIR SODIUM30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3L12PT535M
Rxcui2475199, 2475205

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba89f589-ed67-48fe-9931-d0915055348aProduct name120220728
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
dc78e92e-f760-407c-94a4-da4867af6b2bProduct name120210204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-248-13Vocabria30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-248-13EA - Each49702-2484a4ee8c3-6963-4f27-8692-736e83642e2912021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-248VOCABRIA (CABOTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]8Current NDC, Legacy NDC, 1 package rows20250418_66d450fb-cca4-476c-b0c7-c0730e3e4cf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475199cabotegravir 30 MG Oral TabletPSN66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475205VOCABRIA 30 MG Oral TabletPSN66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475205cabotegravir 30 MG Oral Tablet [Vocabria]SBD66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475199cabotegravir 30 MG Oral TabletSCD66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475199cabotegravir 30 MG (as cabotegravir sodium 31.62 MG) Oral TabletSY66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475205Vocabria 30 MG (as cabotegravir sodium 31.62 MG) Oral TabletSY66d450fb-cca4-476c-b0c7-c0730e3e4cf38
2475205Vocabria 30 MG Oral TabletSY66d450fb-cca4-476c-b0c7-c0730e3e4cf38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-248-134970202481330 TABLET, FILM COATED in 1 BOTTLE (49702-248-13) 2021-01-210000-00-00NoNoCurrent