Prescription drug · ANDA
Dicyclomine hydrochloride NDC 67296-2158
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2158-3 | 67296215803 | 30 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 Drug
- 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
N467296215803followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 217531
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1513 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-634 |