Chlordiazepoxide hydrochloride and clidinium bromide
- Product NDC
- 46708-744
- 11-digit product format
- 467080744
- Labeler code
- 46708
- Product ID
- 46708-744_398931c6-4954-4bbc-8b63-ea382e5864fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlordiazepoxide hydrochloride and clidinium bromide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216969
- Marketing category
- ANDA
- Marketing start
- 2023-10-04
- 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]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlordiazepoxide hydrochloride and clidinium bromide
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-744-31 | Chlordiazepoxide hydrochloride and clidinium bromide | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 46708-744-91 | Chlordiazepoxide hydrochloride and clidinium bromide | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-744 | CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20231006_398931c6-4954-4bbc-8b63-ea382e5864fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-744-31 | 46708074431 | 100 CAPSULE in 1 BOTTLE (46708-744-31) | 100 capsule | 2023-10-04 | No | No | Current |
| 46708-744-91 | 46708074491 | 1000 CAPSULE in 1 BOTTLE (46708-744-91) | 1000 capsule | 2023-10-04 | No | No | Current |