Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 16571-260
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-260-01 | 1657102600116571026001 | 100 CAPSULE in 1 BOTTLE (16571-260-01)Marketed from Jun 23, 2025 | |
| 16571-260-10 | 1657102601016571026010 | 1000 CAPSULE in 1 BOTTLE (16571-260-10)Marketed from Jun 23, 2025 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219242
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 16571-260_239ecf22-4237-4f27-b17c-6fddabcc9d9dSPL ID 239ecf22-4237-4f27-b17c-6fddabcc9d9dSPL set ID 029baf6d-4e85-48fd-9efc-158fe0f629bbRxCUI 991061UNII 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
N416571026001followed by a unit qualifier and the quantityPackage 16571-0260-01. 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 capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules 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.
About NDC 16571-260
- What is NDC 16571-260?
- 16571-260 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 10 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dicyclomine Hydrochloride.
- What is the active ingredient?
- Dicyclomine hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dicyclomine Hydrochloride?
- 126 other product NDCs are listed under this name. See all Dicyclomine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dicyclomine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0883 | 00054-0883-2500054-0883-31 |
| dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0885 | 00054-0885-2500054-0885-31 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4146 | 68788-4146-03 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Advagen Pharma Ltd., | 72888-105 | 72888-0105-0072888-0105-0172888-0105-05+1 more |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-007 | 87441-0007-01 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1258 | 67046-1258-03 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Coupler LLC | 67046-1164 | 67046-1164-03 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-103 | 82868-0103-30 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4555 | 70518-4555-00 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-522 | 72789-0522-0172789-0522-2072789-0522-28+5 more |