Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 71335-2341
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2341-1 | 71335234101 | 30 TABLET in 1 BOTTLE (71335-2341-1)Marketed from Feb 6, 2024 | |
| 71335-2341-2 | 71335234102 | 40 TABLET in 1 BOTTLE (71335-2341-2)Marketed from Feb 6, 2024 | |
| 71335-2341-3 | 71335234103 | 60 TABLET in 1 BOTTLE (71335-2341-3)Marketed from Feb 6, 2024 | |
| 71335-2341-4 | 71335234104 | 90 TABLET in 1 BOTTLE (71335-2341-4)Marketed from Feb 6, 2024 | |
| 71335-2341-5 | 71335234105 | 20 TABLET in 1 BOTTLE (71335-2341-5)Marketed from Feb 6, 2024 | |
| 71335-2341-6 | 71335234106 | 21 TABLET in 1 BOTTLE (71335-2341-6)Marketed from Feb 6, 2024 | |
| 71335-2341-7 | 71335234107 | 120 TABLET in 1 BOTTLE (71335-2341-7)Marketed from Feb 6, 2024 | |
| 71335-2341-8 | 71335234108 | 100 TABLET in 1 BOTTLE (71335-2341-8)Marketed from Feb 6, 2024 | |
| 71335-2341-9 | 71335234109 | 28 TABLET in 1 BOTTLE (71335-2341-9)Marketed from Feb 6, 2024 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040317
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2341_8821239c-0d7f-4b89-90ba-554ca3e3d66aSPL ID 8821239c-0d7f-4b89-90ba-554ca3e3d66aSPL set ID 226a3a6e-9419-448a-827f-01199b792762RxCUI 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
N471335234101followed by a unit qualifier and the quantityPackage 71335-2341-01. 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 is indicated for the treatment of patients with functional bowel/ irritable bowel syndrome. Dicyclomine 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 040317
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 | St. Mary's Medical Park Pharmacy | 60760-665 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3606 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-007 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2612 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Redpharm Drug | 67296-2154 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4393 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Coupler LLC | 67046-1164 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3555 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-720 |