NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1559Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1559Add 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
51662-1559-3516621559035 POUCH in 1 CASE (51662-1559-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 19, 2021

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/mL
Dosage form
Injection, Solution
Route
Intramuscular
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210257
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 51662-1559_0f8de121-b5e5-3048-e063-6294a90afd7cSPL ID 0f8de121-b5e5-3048-e063-6294a90afd7cSPL set ID c77ef2f7-a846-5e05-e053-2995a90aaae0RxCUI 991065UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N451662155903 followed by a unit qualifier and the quantity

Package 51662-1559-03. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210257

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

FDA NDC Directory listings under ANDA 210257
ProductStrengthForm · routeLabelerProduct NDC
Dicyclomine HydrochlorideDicyclomine hydrochloride 10 mg/mLInjection, SolutionIntramuscularFresenius Kabi USA, LLC63323-842

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