Prescription drug · ANDA
Dicyclomine (Dicyclomine hydrochloride) NDC 0143-1227
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-1227-01 | 00143122701 | 100 TABLET in 1 BOTTLE, PLASTIC (0143-1227-01)Marketed from Oct 1, 1996 | |
| 0143-1227-10 | 00143122710 | 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1227-10)Marketed from Oct 1, 1996 |
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
- Generic name (nonproprietary)
- dicyclomine hydrochloride
- Active ingredients
- Dicyclomine hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- 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 0143-1227_ab1abd30-25fd-46ed-a992-925836112c98SPL ID ab1abd30-25fd-46ed-a992-925836112c98SPL set ID 5a553bda-1e3d-4b80-913f-73dd54655033RxCUI 991086UNII CQ903KQA31UPC 0301431227012
- 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
N400143122701followed by a unit qualifier and the quantityPackage 00143-1227-01. 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 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 0143-1227
- What is NDC 0143-1227?
- 0143-1227 is the product NDC for Dicyclomine (dicyclomine hydrochloride), Dicyclomine hydrochloride 20 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 | NuCare Pharmaceuticals, Inc. | 68071-3782 | 68071-3782-0368071-3782-06 |
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 | NuCare Pharmaceuticals, Inc. | 68071-3782 |
| dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0885 |