Chlordiazepoxide hydrochloride and clidinium bromide NDC 46708-744

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-744Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0744Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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 Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216969
Marketing start: Oct 4, 2023
Listing expires: Dec 31, 2026
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

N446708074431 followed by a unit qualifier and the quantity

Package 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 Oct 5, 2023. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216969

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216969
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