Orphenadrine Citrate

Product NDC: 0591-3222
11-digit product format: 005913222
Labeler code: 0591
Product ID: 0591-3222_76bd2057-e1ac-4529-9663-f6139218eeab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Actavis Pharma, Inc.
Application: ANDA084779
Marketing category: ANDA
Marketing start: 2010-07-08
Substance: ORPHENADRINE CITRATE
Active strength: 30 mg/mL
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ORPHENADRINE CITRATE	30 mg/mL

Field, Values table
Field	Values
Unii	X0A40N8I4S
Rxcui	994541

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3222-02	Orphenadrine Citrate	2 mL in 1 AMPULE	INJECTION	2		6
0591-3222-47	Orphenadrine Citrate	10 in 1 CARTON	INJECTION	10		6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3222-02	ML - Milliliter	0591-3222	c531c63e-aa0a-4f93-8e4f-bf73b32741e8	1	2012-07-24
0591-3222-47	ML - Milliliter	0591-3222	6deb2797-6447-4f13-9184-ab65397824b0	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORPHENADRINE CITRATE INJECTION [WATSON LABORATORIES, INC.]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3222	ORPHENADRINE CITRATE INJECTION [ACTAVIS PHARMA, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20181201_aec8ad3a-f717-4e74-b7b9-19debdaad79a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0A40N8I4S	ORPHENADRINE CITRATE	4682-36-4	ORPHENADRINE CITRATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994541	orphenadrine citrate 60 MG in 2 ML Injection	PSN	aec8ad3a-f717-4e74-b7b9-19debdaad79a	6
994541	2 ML orphenadrine citrate 30 MG/ML Injection	SCD	aec8ad3a-f717-4e74-b7b9-19debdaad79a	6
994541	orphenadrine citrate 60 MG per 2 ML Injection	SY	aec8ad3a-f717-4e74-b7b9-19debdaad79a	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3222-02	00591322202	2 mL in 1 AMPULE	2 ml					Historical
0591-3222-47	00591322247	10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02)	10 ampule	2010-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORPHENADRINE CITRATE INJECTION, USP Rx Only	Actavis Pharma, Inc.	2016-07-20	HUMAN PRESCRIPTION DRUG LABEL	6