Librax
- Product NDC
- 0187-4100
- 11-digit product format
- 001874100
- Labeler code
- 0187
- Product ID
- 0187-4100_98fd8b52-2fc3-4540-8333-75b5c853aee2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlordiazepoxide Hydrochloride and Clidinium Bromide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA012750
- Marketing category
- NDA
- Marketing start
- 1966-09-01
- Substance
- CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
- Active strength
- 5; 2.5 mg/1; mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Librax
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | 5 mg/1 |
| CLIDINIUM BROMIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MFM6K1XWDK, 91ZQW5JF1Z |
| Rxcui | 889614, 889616 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-4100-10 | Librax | 100 in 1 BOTTLE | CAPSULE | 100 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-4100 | LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [BAUSCH HEALTH US, LLC] | 16 | Current NDC, Legacy NDC, 1 package rows | 20230425_f99ebf66-f207-4a97-9666-4da1d72b061c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-4100-10 | 00187410010 | 100 CAPSULE in 1 BOTTLE (0187-4100-10) | 100 capsule | 1966-09-01 | 0000-00-00 | No | No | Current |