Prescription drug · ANDA
Chlordiazepoxide Hydrochloride and Clidinium Bromide NDC 11534-197
Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 · Capsule · Oral · Sunrise Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-197-01 | 11534019701 | 100 CAPSULE in 1 BOTTLE (11534-197-01)Marketed from Jul 9, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Chlordiazepoxide Hydrochloride and Clidinium Bromide
- Generic name (nonproprietary)
- chlordiazepoxide hydrochloride and clidinium bromide
- Active ingredients
- Chlordiazepoxide hydrochloride — 5 mg/1Clidinium bromide — 2.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sunrise Pharmaceutical, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211421
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)Cholinergic Antagonists (Mechanism)Decreased Parasympathetic Acetylcholine Activity (Physiologic effect)Digestive/GI System Activity Alteration (Physiologic effect)GI Motility Alteration (Physiologic effect)
- Identifiers
- Product ID 11534-197_3ecf4af2-f5a1-43f1-ac8b-bf88037950d5SPL ID 3ecf4af2-f5a1-43f1-ac8b-bf88037950d5SPL set ID 3cce1912-e7c8-4f30-bd76-dfa4b9d65bacRxCUI 889614UNII MFM6K1XWDK, 91ZQW5JF1ZUPC 0311534197013
- Pharmacologic class
- Anticholinergic; Benzodiazepine
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
N411534019701followed by a unit qualifier and the quantityPackage 11534-0197-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211421
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 |
|---|---|---|---|---|
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1237 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9764 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2966 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2373 |