Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 68071-3255
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3255-1 | 68071325501 | 10 TABLET in 1 BOTTLE (68071-3255-1)Marketed from Jun 8, 2017 | |
| 68071-3255-2 | 68071325502 | 20 TABLET in 1 BOTTLE (68071-3255-2)Marketed from Jun 8, 2017 | |
| 68071-3255-3 | 68071325503 | 30 TABLET in 1 BOTTLE (68071-3255-3)Marketed from Jun 8, 2017 | |
| 68071-3255-5 | 68071325505 | 15 TABLET in 1 BOTTLE (68071-3255-5)Marketed from Jun 8, 2017 | |
| 68071-3255-6 | 68071325506 | 60 TABLET in 1 BOTTLE (68071-3255-6)Marketed from Jun 8, 2017 | |
| 68071-3255-8 | 68071325508 | 28 TABLET in 1 BOTTLE (68071-3255-8)Marketed from Jun 8, 2017 | |
| 68071-3255-9 | 68071325509 | 90 TABLET in 1 BOTTLE (68071-3255-9)Marketed from Jun 8, 2017 |
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
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085223
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 68071-3255_1cc31537-db23-8244-e063-6394a90a3797SPL ID 1cc31537-db23-8244-e063-6394a90a3797SPL set ID 517646d8-366e-5cf2-e054-00144ff88e88RxCUI 991086UNII CQ903KQA31UPC 0368071325522
- 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
N468071325501followed by a unit qualifier and the quantityPackage 68071-3255-01. 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 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 085223
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 | Actavis Pharma, Inc. | 0591-0795 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-045 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Proficient Rx LP | 63187-784 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-257 |