Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 50268-199
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-199-15 | 50268019915 | 50 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)Marketed from Mar 20, 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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217054
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 50268-199_54ed706a-db65-4f5f-e063-6394a90a7078SPL ID 54ed706a-db65-4f5f-e063-6394a90a7078SPL set ID 141d3818-7a87-aaa0-e063-6294a90a4866RxCUI 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
N450268019915followed by a unit qualifier and the quantityPackage 50268-0199-15. 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 capsules are 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 217054
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 | Upsher-Smith Laboratories, LLC | 24979-201 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7340 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7341 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9709 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Redpharm Drug | 67296-2310 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4432 |