OLINVYK

Product NDC: 71308-011
Requested package NDC: 71308-011-10
11-digit product format: 713080011
Labeler code: 71308
Product ID: 71308-011_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: 1 mg/mL
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71308-011	71308-011-10	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210730-001	OLINVYK	OLICERIDINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30
N210730-002	OLINVYK	OLICERIDINE	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30
N210730-003	OLINVYK	OLICERIDINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210730-001	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01
N210730-001	11931350	2032-03-23	U-2986	Drug substance	2024-04-09
N210730-001	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-001	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-001	9642842	2032-03-23	U-2986	Drug product	2020-11-20
N210730-002	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01
N210730-002	11931350	2032-03-23	U-2986	Drug substance	2024-04-09
N210730-002	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-002	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-002	9642842	2032-03-23	U-2986	Drug product	2020-11-20
N210730-003	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01
N210730-003	11931350	2032-03-23	U-2986	Drug substance	2024-04-09
N210730-003	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-003	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20
N210730-003	9642842	2032-03-23	U-2986	Drug product	2020-11-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-002	OLINVYK	2MG/2ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-003	OLINVYK	30MG/30ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210730-001	OLINVYK	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-30	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 498 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210730-001	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-001	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-001	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-001	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-001	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-002	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210730-003	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210730-001	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-001	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-001	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-001	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-001	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-002	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210730-003	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210730-001	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-001	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-001	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-001	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-001	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	11077098	2032-03-23	U-2986	Drug substance, Drug product	2021-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	11931350	2032-03-23	U-2986	Drug substance	2024-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	8835488	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	9309234	2032-03-23	U-2986	Drug substance, Drug product	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210730-002	9642842	2032-03-23	U-2986	Drug product	2020-11-20	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-001	NCE	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-002	NCE	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210730-003	NCE	2025-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210730-001	NCE	2025-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210730-002	NCE	2025-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210730-003	NCE	2025-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-001	NCE	2025-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-002	NCE	2025-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210730-003	NCE	2025-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-001	NCE	2025-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-002	NCE	2025-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210730-003	NCE	2025-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-001	NCE	2025-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-002	NCE	2025-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210730-003	NCE	2025-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-001	NCE	2025-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-002	NCE	2025-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210730-003	NCE	2025-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-001	NCE	2025-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-002	NCE	2025-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210730-003	NCE	2025-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-001	NCE	2025-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-002	NCE	2025-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210730-003	NCE	2025-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210730-001	NCE	2025-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210730-002	NCE	2025-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210730-003	NCE	2025-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-001	NCE	2025-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-002	NCE	2025-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210730-003	NCE	2025-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210730-001	NCE	2025-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210730-002	NCE	2025-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210730-003	NCE	2025-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210730-001	NCE	2025-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210730-002	NCE	2025-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210730-003	NCE	2025-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210730-001	NCE	2025-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210730-002	NCE	2025-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210730-003	NCE	2025-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210730-001	NCE	2025-10-30	`5c6f7cd8ea54…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLICERIDINE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MCN858TCP0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2392234	Internal RxNorm lookup
2392239	Internal RxNorm lookup
2392242	Internal RxNorm lookup
2392243	Internal RxNorm lookup
2392244	Internal RxNorm lookup
2392245	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ce167984-8b9d-40b7-84ce-d0f33fff1eaa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ad8d2206-9275-4fad-b830-8f87044aacdb	Product name	1	20210225
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71308-011-10	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
71308-011-10	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
71308-011-01	OLINVYK	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		11
71308-011-10	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
71308-011	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLINVYK	OLICERIDINE	Trevena, Inc.	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210730 application number: NDA210730 ndc (package): 71308-011-10 ndc (product): 71308-011 ndc11 (package): 71308001110

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MCN858TCP0	OLICERIDINE	1401028-24-7	OLICERIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2392234	oliceridine 1 MG in 1 ML Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392242	oliceridine 2 MG in 2 ML Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392244	oliceridine 30 MG in 30 ML (For PCA Use Only) Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392239	Olinvyk 1 MG in 1 ML Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392243	Olinvyk 2 MG in 2 ML Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392245	Olinvyk 30 MG in 30 ML (For PCA Use Only) Injection	PSN	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392239	1 ML oliceridine 1 MG/ML Injection [Olinvyk]	SBD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392243	2 ML oliceridine 1 MG/ML Injection [Olinvyk]	SBD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392245	30 ML oliceridine 1 MG/ML Injection [Olinvyk]	SBD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392234	1 ML oliceridine 1 MG/ML Injection	SCD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392242	2 ML oliceridine 1 MG/ML Injection	SCD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392244	30 ML oliceridine 1 MG/ML Injection	SCD	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392234	1 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392239	1 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392239	1 ML Olinvyk 1 MG/ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392242	2 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392243	2 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392243	2 ML Olinvyk 1 MG/ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392244	30 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392245	30 ML Olinvyk 1 MG/ML (as oliceridine fumarate 1.3 MG / 1 ML) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392245	30 ML Olinvyk 1 MG/ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392234	oliceridine 1 MG per 1 ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392242	oliceridine 2 MG per 2 ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392244	oliceridine 30 MG per 30 ML (For PCA Use Only) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392239	Olinvyk 1 MG per 1 ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392243	Olinvyk 2 MG per 2 ML Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11
2392245	Olinvyk 30 MG per 30 ML (For PCA Use Only) Injection	SY	ce167984-8b9d-40b7-84ce-d0f33fff1eaa	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71308-011-10	71308001110	10 VIAL, SINGLE-DOSE in 1 CARTON (71308-011-10) / 1 mL in 1 VIAL, SINGLE-DOSE (71308-011-01)	2020-08-07	0000-00-00	No	No	Current