Prescription drug · ANDA
Chlordiazepoxide hydrochloride and clidinium bromide NDC 46708-744
Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-744-31 | 46708074431 | 100 CAPSULE in 1 BOTTLE (46708-744-31)Marketed from Oct 4, 2023 | |
| 46708-744-91 | 46708074491 | 1000 CAPSULE in 1 BOTTLE (46708-744-91)Marketed from Oct 4, 2023 |
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
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216969
- 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 46708-744_398931c6-4954-4bbc-8b63-ea382e5864fcSPL ID 398931c6-4954-4bbc-8b63-ea382e5864fcSPL set ID 398931c6-4954-4bbc-8b63-ea382e5864fcRxCUI 889614UNII MFM6K1XWDK, 91ZQW5JF1Z
- 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
N446708074431followed by a unit qualifier and the quantityPackage 46708-0744-31. 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.
About NDC 46708-744
- What is NDC 46708-744?
- 46708-744 is the product NDC for Chlordiazepoxide hydrochloride and clidinium bromide, Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlordiazepoxide hydrochloride and clidinium bromide.
- What is the active ingredient?
- Chlordiazepoxide hydrochloride, Clidinium bromide.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlordiazepoxide hydrochloride and clidinium bromide?
- 14 other product NDCs are listed under this name. See all Chlordiazepoxide hydrochloride and clidinium bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlordiazepoxide hydrochloride and clidinium bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlordiazepoxide hydrochloride and clidinium bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-744 | 62332-0744-3162332-0744-91 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-524 | 59651-0524-01 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | American Health Packaging | 60687-639 | 60687-0639-94 |
| chlordiazepoxide hydrochloride and clidinium bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1677 | 60219-1677-01 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8859 | 63629-8859-01 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-731 | 67877-0731-0167877-0731-0567877-0731-38 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Winder Laboratories LLC | 75826-134 | 75826-0134-10 |
| Chlordiazepoxide Hydrochloride And Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-696 | 62135-0696-12 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromidechlordiazepoxide hydrochloride, clidinium bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc | 0276-0500 | 00276-0500-10 |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide | Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 | CapsuleOral | Sunrise Pharmaceutical, Inc. | 11534-197 | 11534-0197-01 |
All 15 Chlordiazepoxide hydrochloride and clidinium bromide NDCs
Other NDCs under ANDA 216969
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 | Alembic Pharmaceuticals Inc. | 62332-744 |