What is NDC 0054-0622?

0054-0622 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/5mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dicyclomine Hydrochloride?

126 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	0005406226300054062263	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.NDC labeler code 0054
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)

About NDC 0054-0622

What is NDC 0054-0622?: 0054-0622 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/5mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dicyclomine Hydrochloride.
What is the active ingredient?: Dicyclomine hydrochloride.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dicyclomine Hydrochloride?: 126 other product NDCs are listed under this name. See all Dicyclomine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dicyclomine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
dicyclomine hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Hikma Pharmaceuticals USA Inc.	0054-0883	00054-0883-2500054-0883-31
dicyclomine hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0885	00054-0885-2500054-0885-31
Dicyclomine hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4146	68788-4146-03
Dicyclomine hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Advagen Pharma Ltd.,	72888-105	72888-0105-0072888-0105-0172888-0105-05+1 more
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-007	87441-0007-01
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-1258	67046-1258-03
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	Coupler LLC	67046-1164	67046-1164-03
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	Northwind Health Company, LLC	82868-103	82868-0103-30
Dicyclomine hydrochloride	Dicyclomine hydrochloride 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4555	70518-4555-00
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-522	72789-0522-0172789-0522-2072789-0522-28+5 more

All 127 Dicyclomine Hydrochloride NDCs