Levbid (Hyoscyamine sulfate) NDC 68220-115 converts to 68220-0115-10 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.
openFDA Live Registry Sync•HIPAA 5-4-2 Standard•CMS Level II Crosswalk
Listing: 68220-115
Billing & reimbursement crosswalk
NDC • HCPCS Level II • CPT administration
Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
68220-0115-10
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry
All registered strengths & packaging
Every registered strength and package for Levbid, with 10-digit and 11-digit NDC formats
Formulation / role
Package NDC
Product NDC
11-digit HIPAA
Packaging detail
Copy
.375 mg/1
68220-115-10
68220-115
68220-0115-10
1 TABLET, EXTENDED RELEASE in 1 BOTTLE (68220-115-10)
FDA drug label
Prescribing information
Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.
9 Label Sections
INDICATIONS AND USAGE Levbid ® is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Levbid ® is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of Parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the conditions and severity of symptoms. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.
CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Levbid ® may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
ADVERSE REACTIONS All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.