Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 71335-0938
Dicyclomine hydrochloride 10 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0938-1 | 71335093801 | 30 CAPSULE in 1 BOTTLE (71335-0938-1)Marketed from Feb 9, 2022 | |
| 71335-0938-2 | 71335093802 | 90 CAPSULE in 1 BOTTLE (71335-0938-2)Marketed from Feb 9, 2022 | |
| 71335-0938-3 | 71335093803 | 40 CAPSULE in 1 BOTTLE (71335-0938-3)Marketed from Feb 9, 2022 | |
| 71335-0938-4 | 71335093804 | 60 CAPSULE in 1 BOTTLE (71335-0938-4)Marketed from Feb 9, 2022 | |
| 71335-0938-5 | 71335093805 | 20 CAPSULE in 1 BOTTLE (71335-0938-5)Marketed from Feb 9, 2022 | |
| 71335-0938-6 | 71335093806 | 100 CAPSULE in 1 BOTTLE (71335-0938-6)Marketed from Feb 9, 2022 | |
| 71335-0938-7 | 71335093807 | 180 CAPSULE in 1 BOTTLE (71335-0938-7)Marketed from Feb 9, 2022 | |
| 71335-0938-8 | 71335093808 | 120 CAPSULE in 1 BOTTLE (71335-0938-8)Marketed from Feb 9, 2022 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085082
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 71335-0938_d5fd4345-913c-4236-9dec-1178b63af68bSPL ID d5fd4345-913c-4236-9dec-1178b63af68bSPL set ID b3b8ee01-ec7c-4b17-a237-59ba45cdf3f9RxCUI 991061UNII 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
N471335093801followed by a unit qualifier and the quantityPackage 71335-0938-01. 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 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 ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 085082
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 | PD-Rx Pharmaceuticals, Inc. | 43063-112 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3310 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-0794 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 71205-428 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-219 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-629 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-923 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 66267-291 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | QPharma, Inc. | 42708-160 |