Dicyclomine hydrochloride NDC 43547-634

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0634Add 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
43547-634-10	43547063410	100 CAPSULE in 1 BOTTLE (43547-634-10)Marketed from Aug 23, 2022
43547-634-11	43547063411	1000 CAPSULE in 1 BOTTLE (43547-634-11)Marketed from Aug 23, 2022
43547-634-50	43547063450	500 CAPSULE in 1 BOTTLE (43547-634-50)Marketed from Aug 23, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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/1
Dosage form: Capsule
Route: Oral
Labeler: Solco Healthcare US,LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217531
Marketing start: Aug 23, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 43547-634_d0954a7a-812b-487e-8c22-2a2a58303277SPL ID d0954a7a-812b-487e-8c22-2a2a58303277SPL set ID d0954a7a-812b-487e-8c22-2a2a58303277RxCUI 991061UNII CQ903KQA31UPC 0343547634100
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

N443547063410 followed by a unit qualifier and the quantity

Package 43547-0634-10. 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 Jul 28, 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)

Other NDCs under ANDA 217531

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217531
Product	Strength	Form · route	Labeler	Product NDC
Dicyclomine hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-1513
Dicyclomine hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Redpharm Drug	67296-2158