Levorphanol Tartrate

Product NDC: 42358-103
11-digit product format: 423580103
Labeler code: 42358
Product ID: 42358-103_4462b208-8ef1-49dc-a55a-bdc6d0df8951
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levorphanol Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Sentynl Therapeutics, Inc.
Application: ANDA074278
Marketing category: ANDA
Marketing start: 2018-06-18
Marketing end: 2023-02-28
Substance: LEVORPHANOL TARTRATE
Active strength: 3 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42358-103		D	Discontinued by firm		2026-08-11
excluded package	package	42358-103	42358-103-10	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42358-103-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42358-103-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42358-103-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42358-103-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42358-103-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42358-103-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42358-103-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42358-103-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42358-103-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42358-103-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42358-103-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42358-103-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A074278-001	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31
A074278-002	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18
A074278-003	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074278-001	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074278-002	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL		2018-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074278-003	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		2018-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074278-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2000-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074278-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074278-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074278-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074278-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074278-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074278-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074278-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074278-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074278-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074278-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074278-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074278-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074278-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074278-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074278-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074278-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074278-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074278-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074278-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074278-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074278-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074278-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074278-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074278-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074278-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074278-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074278-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074278-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074278-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074278-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074278-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074278-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074278-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074278-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074278-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074278-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074278-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074278-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074278-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074278-001	AB	1	`a67488948f0b…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42358-103-10	EA - Each	42358-103	843220f6-d754-43b9-88a2-89ad23123454	1	2019-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVORPHANOL TARTRATE	ACTIVE INGREDIENT	04WQU6T9QI	LEVORPHANOL TARTRATE TABLET [SENTYNL THERAPEUTICS, INC.]	2
LEVORPHANOL	ACTIVE MOIETY	27618J1N2X	LEVORPHANOL TARTRATE TABLET [SENTYNL THERAPEUTICS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LEVORPHANOL TARTRATE TABLET [SENTYNL THERAPEUTICS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVORPHANOL TARTRATE TABLET [SENTYNL THERAPEUTICS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVORPHANOL TARTRATE TABLET [SENTYNL THERAPEUTICS, INC.]	2

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
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	Hikma Pharmaceuticals USA Inc.	b2ab70e4-ca0c-4a73-9c98-974bf94e890c	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074278 application number: ANDA074278

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
04WQU6T9QI	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42358-103-10	42358010310	100 TABLET in 1 BOTTLE, PLASTIC (42358-103-10)	100 tablet	2018-06-18	2023-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVORPHANOL TARTRATE TABLETS USP, CII	Sentynl Therapeutics, Inc.	2021-01-30	HUMAN PRESCRIPTION DRUG LABEL	18