LEVORPHANOL TARTRATE

Product NDC: 0054-0438
11-digit product format: 000540438
Labeler code: 0054
Product ID: 0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVORPHANOL TARTRATE
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA074278
Marketing category: ANDA
Marketing start: 2000-03-31
Substance: LEVORPHANOL TARTRATE
Active strength: 2 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVORPHANOL TARTRATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04WQU6T9QI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197873	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
b2ab70e4-ca0c-4a73-9c98-974bf94e890c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
34ec43f3-43ad-c434-04a6-9d47021af3a1	Product name	5	20220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0438-25	LEVORPHANOL TARTRATE	100 in 1 BOTTLE, PLASTIC	TABLET	100		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0438-25	EA - Each	0054-0438	0f48e528-c87a-4d02-b4f2-1916346943e9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVORPHANOL TARTRATE	ACTIVE INGREDIENT	04WQU6T9QI	LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]	7
LEVORPHANOL	ACTIVE MOIETY	27618J1N2X	LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0438	LEVORPHANOL TARTRATE TABLET [HIKMA PHARMACEUTICALS USA INC.]	14	Current NDC, 1 package rows	20240202_b2ab70e4-ca0c-4a73-9c98-974bf94e890c.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
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 ndc (product): 0054-0438

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197873	levorphanol tartrate 2 MG Oral Tablet	PSN	b2ab70e4-ca0c-4a73-9c98-974bf94e890c	17
197873	levorphanol tartrate 2 MG Oral Tablet	SCD	b2ab70e4-ca0c-4a73-9c98-974bf94e890c	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0054-0438-25	00054043825	100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)	100 tablet	2023-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVORPHANOL TARTRATE TABLETS USP, CII R x Only	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	17