Nalbuphine Hydrochloride

Product NDC: 0409-1465
11-digit product format: 004091465
Labeler code: 0409
Product ID: 0409-1465_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: ANDA070916
Marketing category: ANDA
Marketing start: 2004-12-31
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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-1465-01	Nalbuphine Hydrochloride	10 in 1 TRAY	INJECTION, SOLUTION	10		34
0409-1465-71	Nalbuphine Hydrochloride	1 mL in 1 AMPULE	INJECTION, SOLUTION	1		34

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1465-01	ML - Milliliter	0409-1465	ffeabca7-cdda-4aeb-ad71-873391c7f54c	1	2012-07-24
0409-1465-49	ML - Milliliter	0409-1465	9d3c3902-1d80-4110-beb7-d6e042afe77a	1	2012-07-24
0409-1465-61	ML - Milliliter	0409-1465	27a9e148-74e8-46e6-a3c6-0645f172241e	1	2012-07-24
0409-1465-71	ML - Milliliter	0409-1465	74267656-9289-4f1a-b32c-6a3112ae3cfb	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
0409-1465	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	33	Current NDC, Legacy NDC, 2 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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1465-01	00409146501	10 AMPULE in 1 TRAY (0409-1465-01) / 1 mL in 1 AMPULE (0409-1465-71)	10 ampule	2004-12-31	0000-00-00	No	No	Current
0409-1465-71	00409146571	1 mL in 1 AMPULE	1 ml					Historical