Prescription drug · ANDA
Dicyclomine hydrochloride NDC 31722-079
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-079-01 | 31722007901 | 100 TABLET in 1 BOTTLE (31722-079-01)Marketed from May 7, 2024 | |
| 31722-079-10 | 31722007910 | 1000 TABLET in 1 BOTTLE (31722-079-10)Marketed from May 7, 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217566
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 31722-079_24d1b166-e43d-91de-e063-6394a90ae579SPL ID 24d1b166-e43d-91de-e063-6394a90ae579SPL set ID 0590c805-537e-46d3-9500-f4942c1df2eaRxCUI 991086UNII CQ903KQA31UPC 0331722079013, 0331722079105
- 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
N431722007901followed by a unit qualifier and the quantityPackage 31722-0079-01. 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 tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride tablets are 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 217566
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 | NuCare Pharmaceuticals, Inc. | 68071-3885 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3916 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4555 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Redpharm Drug | 67296-2311 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4146 |