nalmefene hydrochloride

Product NDC: 82432-101
11-digit product format: 824320101
Labeler code: 82432
Product ID: 82432-101_52b8bd13-33cb-4def-a172-8853a39fe4c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nalmefene hydrochloride injection
Dosage form: SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Chengdu Shuode Pharmaceutical Co., Ltd
Application: ANDA216007
Marketing category: ANDA
Marketing start: 2023-11-15
Substance: NALMEFENE HYDROCHLORIDE
Active strength: .1 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216007-001	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15
A216007-002	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216007-002	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216007-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216007-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216007-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-002	AP	1	`301d65b070ca…`
2024-05-31 18:47 UTC	2024-05	A216007-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216007-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216007-002	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-002	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: nalmefene hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALMEFENE HYDROCHLORIDE	.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K7K69QC05X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2592953	Internal RxNorm lookup
2672926	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
22d67228-6c24-47ca-afc7-52ef279520a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e7798c38-a53e-489a-b98c-9f4b01c0aab9	Product name	2	20250731
437f042c-2a66-4faa-b06c-0be5226687fa	Product name	1	20250313
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
c8c002c1-b6e1-4b46-8d55-5530f0dfb1b4	Product name	1	20231013
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82432-101-01	nalmefene hydrochloride	1 mL in 1 VIAL, GLASS	SOLUTION	1		5
82432-101-01	nalmefene hydrochloride	1 in 1 CARTON	SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82432-101	NALMEFENE HYDROCHLORIDE (NALMEFENE HYDROCHLORIDE INJECTION) SOLUTION [CHENGDU SHUODE PHARMACEUTICAL CO., LTD]	5	Current NDC, 2 package rows	20240110_22d67228-6c24-47ca-afc7-52ef279520a0.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
nalmefene hydrochloride	NALMEFENE HYDROCHLORIDE INJECTION	Chengdu Shuode Pharmaceutical Co., Ltd	22d67228-6c24-47ca-afc7-52ef279520a0	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216007 application number: ANDA216007 ndc (product): 82432-101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K7K69QC05X	NALMEFENE HYDROCHLORIDE	58895-64-0	NALMEFENE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2672926	nalmefene 100 MCG in 1 ML Injection	PSN	22d67228-6c24-47ca-afc7-52ef279520a0	5
2592953	nalmefene hydrochloride 2 MG in 2 ML Injection	PSN	22d67228-6c24-47ca-afc7-52ef279520a0	5
2672926	1 ML nalmefene 0.1 MG/ML Injection	SCD	22d67228-6c24-47ca-afc7-52ef279520a0	5
2592953	2 ML nalmefene 1 MG/ML Injection	SCD	22d67228-6c24-47ca-afc7-52ef279520a0	5
2672926	nalmefene (as nalmefene hydrochloride) 100 MCG per 1 ML Injection	SY	22d67228-6c24-47ca-afc7-52ef279520a0	5
2592953	nalmefene (as nalmefene hydrochloride) 2 MG per 2 ML Injection	SY	22d67228-6c24-47ca-afc7-52ef279520a0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82432-101-01	82432010101	1 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS	2023-11-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
nalmefene hydrochloride injection - Chengdu Shuode Pharmaceutical Co., Ltd	Chengdu Shuode Pharmaceutical Co., Ltd	2023-12-08	HUMAN PRESCRIPTION DRUG LABEL	5