NDC 71308-021-01 - OLINVYK

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 71308-021
Requested NDC: 71308-021-01
Package NDCs from labels: 71308-021-01, 71308-021-10
Manufacturer: Trevena, Inc.
Effective date: 2025-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OLINVYK - Trevena, Inc.	Trevena, Inc.	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71308-021-10	2023-03-23	C162847	48780-1	f386c64a-1a5f-0266-e053-dadaa90a7c1a	These 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
71308-021-10	2023-01-30	C162847	48780-1	f386c64a-1a5f-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
71308-021-01	OLINVYK	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		11
71308-021-10	OLINVYK	10 in 1 CARTON	INJECTION, SOLUTION	10		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71308-021	OLINVYK (OLICERIDINE) INJECTION, SOLUTION [TREVENA, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250112_ce167984-8b9d-40b7-84ce-d0f33fff1eaa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Civica, Inc.	3f49eedf-5bf5-4a95-b704-c956d860ca04	2023-04-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Treprostinil	TREPROSTINIL	Sandoz Inc	473297ca-a872-4052-a053-87dc8f0d3c13	2023-04-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
NOVOLOG	INSULIN ASPART	Novo Nordisk	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	2023-02-28	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Rehydrate	AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN	ParaDocs All Natural, Inc.	648fab10-c46b-420f-a42c-6642009d83fb	2023-01-10	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Premasol - sulfite-free (Amino Acid)	LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE	Baxter Healthcare Company	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	2022-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4QD397987E
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E
CLINIMIX	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE	Baxter Healthcare Corporation	dccff103-8695-400c-a15d-cc2fd078760a	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.