NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0425Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0425Add 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
71335-0425-1713350425017133504250130 TABLET in 1 BOTTLE (71335-0425-1)Marketed from Feb 22, 2018
71335-0425-2713350425027133504250240 TABLET in 1 BOTTLE (71335-0425-2)Marketed from Dec 27, 2021
71335-0425-3713350425037133504250360 TABLET in 1 BOTTLE (71335-0425-3)Marketed from Nov 12, 2020
71335-0425-4713350425047133504250490 TABLET in 1 BOTTLE (71335-0425-4)Marketed from Mar 26, 2020
71335-0425-5713350425057133504250520 TABLET in 1 BOTTLE (71335-0425-5)Marketed from May 4, 2018
71335-0425-6713350425067133504250621 TABLET in 1 BOTTLE (71335-0425-6)Marketed from Dec 27, 2021
71335-0425-77133504250771335042507120 TABLET in 1 BOTTLE (71335-0425-7)Marketed from Dec 27, 2021
71335-0425-87133504250871335042508100 TABLET in 1 BOTTLE (71335-0425-8)Marketed from Dec 27, 2021
71335-0425-9713350425097133504250928 TABLET in 1 BOTTLE (71335-0425-9)Marketed from Jun 1, 2020

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 — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040230
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 71335-0425_6964b17a-fd00-46d2-801d-fd732d9219eeSPL ID 6964b17a-fd00-46d2-801d-fd732d9219eeSPL set ID 34db5a80-f445-41e5-b3c4-4c18abb09c92RxCUI 991086UNII 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

N471335042501 followed by a unit qualifier and the quantity

Package 71335-0425-01. 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 .

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 71335-0425

What is NDC 71335-0425?
71335-0425 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 20 mg/1 tablet, 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
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 040230

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

FDA NDC Directory listings under ANDA 040230
ProductStrengthForm · routeLabelerProduct NDC
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralLannett Company, LLC0527-1282
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralMajor Pharmaceuticals0904-6988
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralA-S Medication Solutions50090-1577
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralNorthwind Health Company, LLC51655-940
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralAmerican Health Packaging60687-380
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralChartwell RX, LLC62135-428
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralProficient Rx LP63187-410
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4782
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7811
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralREMEDYREPACK INC.70518-1767
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-209
Dicyclomine HydrochlorideDicyclomine hydrochloride 20 mg/1TabletOralBryant Ranch Prepack72162-1077

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