NDC codes

FDA NDC Directory
Product NDC (as listed)67296-2158Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-2158Add 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 NDC11-digit (billing)PackageCopy
67296-2158-3672962158036729621580330 CAPSULE in 1 BOTTLE (67296-2158-3)Marketed from Aug 23, 2022

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
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217531
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 67296-2158_45d267f6-9cad-b5b1-e063-6294a90a982fSPL ID 45d267f6-9cad-b5b1-e063-6294a90a982fSPL set ID 3745661f-5d24-487d-e063-6294a90a5a68RxCUI 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

N467296215803 followed by a unit qualifier and the quantity

Package 67296-2158-03. 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 .

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 67296-2158

What is NDC 67296-2158?
67296-2158 is the product NDC for Dicyclomine hydrochloride, Dicyclomine hydrochloride 10 mg/1 capsule, listed with the FDA by Redpharm Drug. 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?
Redpharm Drug, NDC labeler code 67296. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
dicyclomine hydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralHikma Pharmaceuticals USA Inc.0054-088300054-0883-2500054-0883-31
dicyclomine hydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-088500054-0885-2500054-0885-31
Dicyclomine hydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-414668788-4146-03
Dicyclomine hydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralAdvagen Pharma Ltd.,72888-10572888-0105-0072888-0105-0172888-0105-05+1 more
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralUnit Dose Solutions, Inc.87441-00787441-0007-01
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-125867046-1258-03
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralCoupler LLC67046-116467046-1164-03
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralNorthwind Health Company, LLC82868-10382868-0103-30
Dicyclomine hydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralREMEDYREPACK INC.70518-455570518-4555-00
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-52272789-0522-0172789-0522-2072789-0522-28+5 more

All 127 Dicyclomine hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Dicyclomine hydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralSolco Healthcare US,LLC43547-634
Dicyclomine hydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-1513

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