What is NDC 71335-2316?

71335-2316 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-2316

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2316Add 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
71335-2316-1	71335231601	30 CAPSULE in 1 BOTTLE (71335-2316-1)Marketed from Jan 2, 2024
71335-2316-2	71335231602	90 CAPSULE in 1 BOTTLE (71335-2316-2)Marketed from Jan 2, 2024
71335-2316-3	71335231603	40 CAPSULE in 1 BOTTLE (71335-2316-3)Marketed from Jan 2, 2024
71335-2316-4	71335231604	60 CAPSULE in 1 BOTTLE (71335-2316-4)Marketed from Jan 2, 2024
71335-2316-5	71335231605	20 CAPSULE in 1 BOTTLE (71335-2316-5)Marketed from Jan 2, 2024
71335-2316-6	71335231606	100 CAPSULE in 1 BOTTLE (71335-2316-6)Marketed from Jan 2, 2024
71335-2316-7	71335231607	180 CAPSULE in 1 BOTTLE (71335-2316-7)Marketed from Jan 2, 2024
71335-2316-8	71335231608	120 CAPSULE in 1 BOTTLE (71335-2316-8)Marketed from Jan 2, 2024
71335-2316-9	71335231609	10 CAPSULE in 1 BOTTLE (71335-2316-9)Marketed from Jan 2, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040319
Marketing start: May 8, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 71335-2316_0cdb0e0b-0f75-403d-a2b7-0386db8ffee5SPL ID 0cdb0e0b-0f75-403d-a2b7-0386db8ffee5SPL set ID 07361f0e-90c7-4531-8d3f-1ec5e7fed40dRxCUI 991061UNII CQ903KQA31
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

N471335231601 followed by a unit qualifier and the quantity

Package 71335-2316-01. 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 Aug 23, 2024.

Indications (excerpt from the label)

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine 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 71335-2316

What is NDC 71335-2316?: 71335-2316 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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

Other NDCs under ANDA 040319

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

FDA NDC Directory listings under ANDA 040319
Product	Strength	Form · route	Labeler	Product NDC
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2613
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-1258
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-719
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8578
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	NuCare Pharmaceuticals, Inc.	68071-3674
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4331