FDA.reportPublic FDA data

OLINVYK

Product NDC
71308-021
11-digit product format
713080021
Labeler code
71308
Product ID
71308-021_43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLICERIDINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Trevena, Inc.
Application
NDA210730
Marketing category
NDA
Marketing start
2020-08-07
Substance
OLICERIDINE
Active strength
2 mg/2mL
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLICERIDINE2 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMCN858TCP0
Rxcui2392234, 2392239, 2392242, 2392243, 2392244, 2392245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ad8d2206-9275-4fad-b830-8f87044aacdbProduct name120210225
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71308-021-102023-03-23C16284748780-1f386c64a-1a5f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLINVYK ® safely and effectively. See full prescribing information for OLINVYK. OLINVYK (oliceridine) injection, for intravenous use, CII Initial U.S. Approval: 2020
71308-021-102023-01-30C16284748780-1f386c64a-1a5f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLINVYK ® safely and effectively. See full prescribing information for OLINVYK. OLINVYK (oliceridine) injection, for intravenous use, CII Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71308-021-01OLINVYK2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION211
71308-021-10OLINVYK10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71308-021OLINVYK (OLICERIDINE) INJECTION, SOLUTION [TREVENA, INC.]10Current NDC, Legacy NDC, 2 package rows20250112_ce167984-8b9d-40b7-84ce-d0f33fff1eaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2392234oliceridine 1 MG in 1 ML InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392242oliceridine 2 MG in 2 ML InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392244oliceridine 30 MG in 30 ML (For PCA Use Only) InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392239Olinvyk 1 MG in 1 ML InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392243Olinvyk 2 MG in 2 ML InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392245Olinvyk 30 MG in 30 ML (For PCA Use Only) InjectionPSNce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922391 ML oliceridine 1 MG/ML Injection [Olinvyk]SBDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922432 ML oliceridine 1 MG/ML Injection [Olinvyk]SBDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
239224530 ML oliceridine 1 MG/ML Injection [Olinvyk]SBDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922341 ML oliceridine 1 MG/ML InjectionSCDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922422 ML oliceridine 1 MG/ML InjectionSCDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
239224430 ML oliceridine 1 MG/ML InjectionSCDce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922341 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922391 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922391 ML Olinvyk 1 MG/ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922422 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922432 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
23922432 ML Olinvyk 1 MG/ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
239224430 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
239224530 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
239224530 ML Olinvyk 1 MG/ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392234oliceridine 1 MG per 1 ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392242oliceridine 2 MG per 2 ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392244oliceridine 30 MG per 30 ML (For PCA Use Only) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392239Olinvyk 1 MG per 1 ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392243Olinvyk 2 MG per 2 ML InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11
2392245Olinvyk 30 MG per 30 ML (For PCA Use Only) InjectionSYce167984-8b9d-40b7-84ce-d0f33fff1eaa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71308-021-01713080021012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71308-021-107130800211010 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01) 2020-08-070000-00-00NoNoCurrent