Prescription drug · ANDA
Dicyclomine (Dicyclomine hydrochloride) NDC 68071-3782
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3782-3 | 68071378203 | 30 TABLET in 1 BOTTLE, PLASTIC (68071-3782-3)Marketed from Jan 23, 2025 | |
| 68071-3782-6 | 68071378206 | 60 TABLET in 1 BOTTLE, PLASTIC (68071-3782-6)Marketed from Feb 24, 2025 |
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
- Generic name (nonproprietary)
- dicyclomine hydrochloride
- Active ingredients
- Dicyclomine hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040161
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 68071-3782_2eea79bd-1ae0-765d-e063-6294a90a16f4SPL ID 2eea79bd-1ae0-765d-e063-6294a90a16f4SPL set ID 2c656550-7e5b-445f-e063-6294a90a8f52RxCUI 991086UNII CQ903KQA31UPC 0368071378238
- 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
N468071378203followed by a unit qualifier and the quantityPackage 68071-3782-03. 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 tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride tablets 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 68071-3782
- What is NDC 68071-3782?
- 68071-3782 is the product NDC for Dicyclomine (dicyclomine hydrochloride), Dicyclomine hydrochloride 20 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dicyclomine (Dicyclomine hydrochloride).
- What is the active ingredient?
- Dicyclomine hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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?
- 1 other product NDC are listed under this name. See all Dicyclomine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dicyclomine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dicyclominedicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1227 | 00143-1227-0100143-1227-10 |
Other NDCs under ANDA 040161
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 |
|---|---|---|---|---|
| Dicyclominedicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1227 |
| dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0885 |