What is NDC 70954-261?

70954-261 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/5mL solution, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Novitium Pharma LLC, NDC labeler code 70954. 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 70954-261

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0261Add 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
70954-261-10	7095402611070954026110	473 mL in 1 BOTTLE (70954-261-10)Marketed from Apr 23, 2021

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/5mL
Dosage form: Solution
Route: Oral
Labeler: Novitium Pharma LLCNDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214721
Marketing start: Apr 23, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 70954-261_b0911994-0b36-439d-8247-5d885a899421SPL ID b0911994-0b36-439d-8247-5d885a899421SPL set ID b0911994-0b36-439d-8247-5d885a899421RxCUI 991082UNII CQ903KQA31UPC 0370954261100
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

N470954026110 followed by a unit qualifier and the quantity

Package 70954-0261-10. 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 Apr 23, 2021.

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 70954-261

What is NDC 70954-261?: 70954-261 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/5mL solution, listed with the FDA by Novitium Pharma LLC. 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?: Novitium Pharma LLC, NDC labeler code 70954. 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 214721

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

FDA NDC Directory listings under ANDA 214721
Product	Strength	Form · route	Labeler	Product NDC
Dicyclomine Hydrochloride	Dicyclomine hydrochloride 10 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-2261