Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 0527-0586
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · Lannett Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-0586-01 | 00527058601 | 100 CAPSULE in 1 BOTTLE (0527-0586-01)Marketed from Sep 30, 1974 | |
| 0527-0586-05 | 00527058605 | 500 CAPSULE in 1 BOTTLE (0527-0586-05)Marketed from Sep 30, 1974 | |
| 0527-0586-10 | 00527058610 | 1000 CAPSULE in 1 BOTTLE (0527-0586-10)Marketed from Sep 30, 1974 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Lannett Company, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084285
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0527-0586_af403376-506f-4533-bae5-bbfde5aecf05SPL ID af403376-506f-4533-bae5-bbfde5aecf05SPL set ID bd2cba10-70ec-4d1f-b46c-53d1de2ee130RxCUI 991061, 991086UNII CQ903KQA31UPC 0305270586019
- 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
N400527058601followed by a unit qualifier and the quantityPackage 00527-0586-01. 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 084285
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 | Chartwell RX, LLC | 62135-718 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 63187-196 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-3565 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3035 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8183 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0471 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6987 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-265 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | American Health Packaging | 60687-369 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0126 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0127 |