Prescription drug · NDA
Librax NDC 0187-4100
chlordiazepoxide hydrochloride and clidinium bromide · Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 · Capsule · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-4100-10 | 00187410010 | 100 CAPSULE in 1 BOTTLE (0187-4100-10)Marketed from Sep 1, 1966 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Librax
- 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
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012750
- Marketing start
- Listing expires
- 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 0187-4100_98fd8b52-2fc3-4540-8333-75b5c853aee2SPL ID 98fd8b52-2fc3-4540-8333-75b5c853aee2SPL set ID f99ebf66-f207-4a97-9666-4da1d72b061cRxCUI 889614, 889616UNII MFM6K1XWDK, 91ZQW5JF1ZUPC 0301874100101
- 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
N400187410010followed by a unit qualifier and the quantityPackage 00187-4100-10. 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: Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax 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 0187-4100
- What is NDC 0187-4100?
- 0187-4100 is the product NDC for Librax, Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 capsule, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Librax (Chlordiazepoxide Hydrochloride and Clidinium Bromide).
- What is the active ingredient?
- Chlordiazepoxide hydrochloride, Clidinium bromide.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Librax?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.