Orphenadrine Citrate

Product NDC: 17478-538
11-digit product format: 174780538
Labeler code: 17478
Product ID: 17478-538_e574a61b-1d1c-4815-97ff-635c719572bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Akorn
Application: ANDA040484
Marketing category: ANDA
Marketing start: 2006-10-17
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-538-02	ML - Milliliter	17478-538	312d606a-5cf7-4966-9b29-4a5ef084be3a	1	2012-07-24

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	30855838-7757-4533-aff7-b5d1369b0524	7
994541	2 ML orphenadrine citrate 30 MG/ML Injection	SCD	30855838-7757-4533-aff7-b5d1369b0524	7
994541	orphenadrine citrate 60 MG per 2 ML Injection	SY	30855838-7757-4533-aff7-b5d1369b0524	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-538-02	17478053802	10 VIAL in 1 CARTON (17478-538-02) > 2 mL in 1 VIAL	10 vial	2006-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORPHENADRINE CITRATE INJECTION, USP	A-S Medication Solutions	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	7