Nalbuphine Hydrochloride

Product NDC: 0409-1467
11-digit product format: 004091467
Labeler code: 0409
Product ID: 0409-1467_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALBUPHINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hospira, Inc.
Application: ANDA070918
Marketing category: ANDA
Marketing start: 2005-05-16
Substance: NALBUPHINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
NALBUPHINE HYDROCHLORIDE	20 mg/mL

Field, Values table
Field	Values
Unii	ZU4275277R
Rxcui	904415, 904440, 1866543, 1866551

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e665fab2-f6df-99b6-a22d-5d9276f14b80	Product name	3	20250331
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-1467-01	Nalbuphine Hydrochloride	25 in 1 CASE	INJECTION, SOLUTION	25	34
0409-1467-61	Nalbuphine Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1	34
0409-1467-61	Nalbuphine Hydrochloride	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	34

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1467-01	ML - Milliliter	0409-1467	22c21913-88f6-4c61-a9c7-41c5c5f95fbd	1	2012-07-24
0409-1467-61	ML - Milliliter	0409-1467	46d2f335-f63a-42d0-9096-111719f87065	1	2020-03-10

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NALBUPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	ZU4275277R	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
NALBUPHINE	ACTIVE MOIETY	L2T84IQI2K	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1467	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	33	Current NDC, Legacy NDC, 3 package rows	20241207_6025e8d4-5083-4c3a-58a0-050e7b0b6150.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZU4275277R	NALBUPHINE HYDROCHLORIDE	23277-43-2	NALBUPHINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1866543	nalbuphine HCl 10 MG in 1 ML Injection	PSN	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
904415	nalbuphine HCl 10 MG/ML Injectable Solution	PSN	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
1866551	nalbuphine HCl 20 MG in 1 ML Injection	PSN	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
904440	nalbuphine HCl 20 MG/ML Injectable Solution	PSN	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
1866543	1 ML nalbuphine hydrochloride 10 MG/ML Injection	SCD	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
1866551	1 ML nalbuphine hydrochloride 20 MG/ML Injection	SCD	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
904415	nalbuphine hydrochloride 10 MG/ML Injectable Solution	SCD	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
904440	nalbuphine hydrochloride 20 MG/ML Injectable Solution	SCD	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
1866543	nalbuphine HCl 10 MG per 1 ML Injection	SY	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
1866551	nalbuphine HCl 20 MG per 1 ML Injection	SY	6025e8d4-5083-4c3a-58a0-050e7b0b6150	34
904440	nalbuphine HCl 20 MG/ML Injectable Solution	PSN	96128b54-24d6-88a3-e053-2a95a90a1c9c	4
904440	nalbuphine hydrochloride 20 MG/ML Injectable Solution	SCD	96128b54-24d6-88a3-e053-2a95a90a1c9c	4
904440	nalbuphine HCl 20 MG/ML Injectable Solution	PSN	28f274a4-62c4-4e54-e063-6394a90a2200	1
904440	nalbuphine hydrochloride 20 MG/ML Injectable Solution	SCD	28f274a4-62c4-4e54-e063-6394a90a2200	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1467-01	00409146701	25 CARTON in 1 CASE (0409-1467-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-61) / 10 mL in 1 VIAL, MULTI-DOSE	25 carton	2005-05-16	0000-00-00	No	No	Current
0409-1467-61	00409146761	1 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	34
NALBUPHINE HCI INJECTION 20mg/mL 10mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	4
NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	1
NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	2024-11-19	HUMAN PRESCRIPTION DRUG LABEL	5