Prescription drug · ANDA
Dicyclomine hydrochloride NDC 0517-1980
Dicyclomine hydrochloride 20 mg/2mL · Injection, Solution · Intramuscular · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-1980-05 | 00517198005 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)Marketed from Sep 11, 2017 | |
| 0517-1980-10 | 00517198010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)Marketed from Sep 11, 2017 |
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 — 20 mg/2mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- American Regent, Inc.NDC labeler code 0517
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208353
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167ddSPL ID 9ffbe6bb-e13f-48d4-a8e0-55936b5167ddSPL set ID cab4ecaf-8895-4ae8-add3-233d9cc570a8RxCUI 991065UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400517198005followed by a unit qualifier and the quantityPackage 00517-1980-05. 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 injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine Hydrochloride Injection, USP 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.
About NDC 0517-1980
- What is NDC 0517-1980?
- 0517-1980 is the product NDC for Dicyclomine hydrochloride, Dicyclomine hydrochloride 20 mg/2mL injection, solution, listed with the FDA by American Regent, 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?
- American Regent, Inc., NDC labeler code 0517. 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?
- 123 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 |