NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0471Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0471Add 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
71335-0471-17133504710130 CAPSULE in 1 BOTTLE (71335-0471-1)Marketed from Feb 9, 2022
71335-0471-27133504710290 CAPSULE in 1 BOTTLE (71335-0471-2)Marketed from Feb 9, 2022
71335-0471-37133504710340 CAPSULE in 1 BOTTLE (71335-0471-3)Marketed from Feb 9, 2022
71335-0471-47133504710460 CAPSULE in 1 BOTTLE (71335-0471-4)Marketed from Feb 9, 2022
71335-0471-57133504710520 CAPSULE in 1 BOTTLE (71335-0471-5)Marketed from Feb 9, 2022
71335-0471-671335047106100 CAPSULE in 1 BOTTLE (71335-0471-6)Marketed from Feb 9, 2022
71335-0471-771335047107180 CAPSULE in 1 BOTTLE (71335-0471-7)Marketed from Feb 9, 2022
71335-0471-871335047108120 CAPSULE in 1 BOTTLE (71335-0471-8)Marketed from Feb 9, 2022
71335-0471-97133504710910 CAPSULE in 1 BOTTLE (71335-0471-9)Marketed from Feb 9, 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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 084285
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 71335-0471_50d57cda-f389-4eed-a4e5-edec4388bb48SPL ID 50d57cda-f389-4eed-a4e5-edec4388bb48SPL set ID 4da6868f-3530-4960-af71-e56439c96e9fRxCUI 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

N471335047101 followed by a unit qualifier and the quantity

Package 71335-0471-01. 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 71335-0471

What is NDC 71335-0471?
71335-0471 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?
127 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 128 Dicyclomine Hydrochloride NDCs

Other NDCs under ANDA 084285

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

FDA NDC Directory listings under ANDA 084285
ProductStrengthForm · routeLabelerProduct NDC
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralMajor Pharmaceuticals0904-6987
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralChartwell RX, LLC62135-718
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralProficient Rx LP63187-196
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-3035
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralCardinal Health 107, LLC55154-3565
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralCardinal Health 107, LLC55154-8183
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralLannett Company, LLC0527-0586
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-265
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralA-S Medication Solutions50090-0126
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralA-S Medication Solutions50090-0127
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralAmerican Health Packaging60687-369

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