Dicyclomine Hydrochloride NDC 0054-0622

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0622Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0054-0622-63	00054062263	473 mL in 1 BOTTLE (0054-0622-63)Marketed from May 22, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dicyclomine Hydrochloride
Generic name (nonproprietary): dicyclomine hydrochloride
Active ingredients: Dicyclomine hydrochloride — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212286
Marketing start: May 22, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0054-0622_8ad8c412-22d6-424f-9a52-48074ab28d4fSPL ID 8ad8c412-22d6-424f-9a52-48074ab28d4fSPL set ID aa5bd79d-7f18-4032-8862-0c5429b2ecafRxCUI 991082UNII CQ903KQA31UPC 0300540622633
Pharmacologic class: Anticholinergic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054062263 followed by a unit qualifier and the quantity

Package 00054-0622-63. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 31, 2023.

Indications (excerpt from the label)

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)