busPIRone HCl
- Product NDC
- 82868-082
- 11-digit product format
- 828680082
- Labeler code
- 82868
- Product ID
- 82868-082_472049db-f1eb-5e2b-e063-6294a90a2ff8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA075521
- Marketing category
- ANDA
- Marketing start
- 2025-06-19
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 7.5 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 HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUSPIRONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207LT9J9OC |
| Rxcui | 866111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-082-30 | busPIRone HCl | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-082-30 | 82868008230 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-082-30) | 30 tablet | 2025-06-19 | No | No | Historical |