NALMEFENE HYDROCHLORIDE

Product NDC: 59011-960
11-digit product format: 590110960
Labeler code: 59011
Product ID: 59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALMEFENE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Knoa Pharma LLC
Application: ANDA212955
Marketing category: ANDA
Marketing start: 2022-02-08
Substance: NALMEFENE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212955-001	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212955-001	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
2026-09-14 22:38:34	2026-08	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2022-02-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212955-001	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	2022-02-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212955-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212955-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212955-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212955-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212955-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212955-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212955-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212955-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212955-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212955-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212955-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212955-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212955-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212955-001	AP	1	`301d65b070ca…`
2024-05-31 18:47 UTC	2024-05	A212955-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212955-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212955-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212955-001	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212955-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2592953	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
3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7	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
c8c002c1-b6e1-4b46-8d55-5530f0dfb1b4	Product name	1	20231013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59011-960-10	NALMEFENE HYDROCHLORIDE	2 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	2		7
59011-960-10	NALMEFENE HYDROCHLORIDE	10 in 1 CARTON	INJECTION, SOLUTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59011-960-10	ML - Milliliter	59011-960	3b314ee7-87c1-4c81-a777-5cab8ba7aa9b	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59011-960	NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION [PURDUE PHARMA L.P.]	5	Current NDC, Legacy NDC, 2 package rows	20241225_3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7.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	Knoa Pharma LLC	3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212955 application number: ANDA212955 ndc (product): 59011-960

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
2592953	nalmefene hydrochloride 2 MG in 2 ML Injection	PSN	3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7	7
2592953	2 ML nalmefene 1 MG/ML Injection	SCD	3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7	7
2592953	nalmefene (as nalmefene hydrochloride) 2 MG per 2 ML Injection	SY	3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59011-960-10	59011096010	10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS	2022-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nalmefene Hydrochloride Injection	Knoa Pharma LLC \| PCI San Diego, Inc.	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	7