Prescription drug · ANDA
Dicyclomine hydrochloride NDC 31722-052
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-052-01 | 3172200520131722005201 | 100 CAPSULE in 1 BOTTLE (31722-052-01)Marketed from Jul 1, 2024 | |
| 31722-052-05 | 3172200520531722005205 | 500 CAPSULE in 1 BOTTLE (31722-052-05)Marketed from Jul 1, 2024 | |
| 31722-052-10 | 3172200521031722005210 | 1000 CAPSULE in 1 BOTTLE (31722-052-10)Marketed from Jul 1, 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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218018
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 31722-052_1e764ead-f2ea-f00c-e063-6294a90ae86bSPL ID 1e764ead-f2ea-f00c-e063-6294a90ae86bSPL set ID 600f3b80-0303-4f2d-929b-edb689b5b357RxCUI 991061UNII CQ903KQA31UPC 0331722052054, 0331722052016
- 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
N431722005201followed by a unit qualifier and the quantityPackage 31722-0052-01. 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 31722-052
- What is NDC 31722-052?
- 31722-052 is the product NDC for Dicyclomine hydrochloride, Dicyclomine hydrochloride 10 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 3 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 |
Other NDCs under ANDA 218018
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 | A-S Medication Solutions | 50090-7729 |