Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 70069-431
Dicyclomine hydrochloride 10 mg/mL · Injection, Solution · Intramuscular · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-431-05 | 70069043105 | 5 VIAL in 1 CARTON (70069-431-05) / 2 mL in 1 VIAL (70069-431-01)Marketed from Nov 5, 2024 |
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/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214332
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 70069-431_a927b130-5b1b-462f-bb0c-2ea8763487eeSPL ID a927b130-5b1b-462f-bb0c-2ea8763487eeSPL set ID 7ad77f59-e24a-406d-95bf-3d5c6cbc3cbeRxCUI 991065UNII CQ903KQA31UPC 0370069431054, 0370069441053, 0370069431016, 0370069441015
- 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.
- NDC on a medical claim
N470069043105followed by a unit qualifier and the quantityPackage 70069-0431-05. 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 injection, USP is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride injection 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.