Buspirone Hydrochloride
- Product NDC
- 42806-833
- 11-digit product format
- 428060833
- Labeler code
- 42806
- Product ID
- 42806-833_160f52d2-2e08-4969-80c3-c653767652f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA218628
- Marketing category
- ANDA
- Marketing start
- 2025-03-13
- Substance
- BUSPIRONE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buspirone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUSPIRONE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TK65WKS8HL |
| Rxcui | 2708991, 2708993, 2708994 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-833-18 | Buspirone Hydrochloride | 180 in 1 BOTTLE | CAPSULE | 180 | | 1 |
| 42806-833-60 | Buspirone Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-833 | BUSPIRONE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20250323_160f52d2-2e08-4969-80c3-c653767652f0.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 |
|---|
| 42806-833-18 | 42806083318 | 180 CAPSULE in 1 BOTTLE (42806-833-18) | 180 capsule | 2025-03-13 | No | No | Current |
| 42806-833-60 | 42806083360 | 60 CAPSULE in 1 BOTTLE (42806-833-60) | 60 capsule | 2025-03-13 | No | No | Current |