Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 50090-7309
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7309-0 | 50090730900 | 30 TABLET in 1 BOTTLE (50090-7309-0)Marketed from Oct 14, 2024 | |
| 50090-7309-2 | 50090730902 | 20 TABLET in 1 BOTTLE (50090-7309-2)Marketed from Oct 14, 2024 | |
| 50090-7309-8 | 50090730908 | 90 TABLET in 1 BOTTLE (50090-7309-8)Marketed from Oct 14, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- dicyclomine hydrochloride
- Active ingredients
- Dicyclomine hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216782
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 50090-7309_bbfd15b7-d21a-461b-a4f2-3cfa965ff6b7SPL ID bbfd15b7-d21a-461b-a4f2-3cfa965ff6b7SPL set ID 1aebc66d-0636-45ef-8110-7ff49d4dced5RxCUI 991086UNII 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
N450090730900followed by a unit qualifier and the quantityPackage 50090-7309-00. 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 is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216782
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 20 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-200 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3645 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3648 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3917 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-821 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-931 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Redpharm Drug | 67296-2294 |