Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 71610-209
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-209-09 | 71610020909 | 9000 TABLET in 1 BOTTLE (71610-209-09)Marketed from Dec 18, 2018 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040230
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 71610-209_dcd1f50a-a200-48b3-89f7-039081a9e72dSPL ID dcd1f50a-a200-48b3-89f7-039081a9e72dSPL set ID da2c43f8-1c3a-447f-8994-f9899fb5e141RxCUI 991086UNII 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
N471610020909followed by a unit qualifier and the quantityPackage 71610-0209-09. 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 040230
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 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-1577 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1767 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-940 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Lannett Company, LLC | 0527-1282 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0425 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6988 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Proficient Rx LP | 63187-410 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4782 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1077 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | American Health Packaging | 60687-380 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7811 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Chartwell RX, LLC | 62135-428 |