Buspirone hydrochloride
- Product NDC
- 68382-623
- 11-digit product format
- 683820623
- Labeler code
- 68382
- Product ID
- 68382-623_8692aee8-7eb4-4cbb-8a31-3ecc49660195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA078888
- Marketing category
- ANDA
- Marketing start
- 2023-03-21
- 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 207LT9J9OC |
| Rxcui | 866018, 866083, 866090, 866094, 866111 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a9968269-ddf2-400e-9170-7376dcf3545a | Product name | 1 | 20251215 |
| 2cf3c2e9-d566-c982-009a-188fe4f776b9 | Product name | 8 | 20200428 |
| 4a9096ce-7b98-89e5-5942-15f48c4f7abf | Product name | 5 | 20190711 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68382-623-01 | Buspirone hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 11 | |
| 68382-623-05 | Buspirone hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 11 | |
| 68382-623-10 | Buspirone hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 11 | |
| 68382-623-30 | Buspirone hydrochloride | 100 in 1 CARTON | TABLET | 100 | 11 | |
| 68382-623-30 | Buspirone hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-623-01 | EA - Each | 68382-623 | cea9e7dc-633e-4067-833e-87011dadf8d6 | 1 | 2023-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | ACTIVE INGREDIENT | 207LT9J9OC | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| BUSPIRONE | ACTIVE MOIETY | TK65WKS8HL | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 08efb26e-488c-49d4-8432-98db855962e9 | 102 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 08efb26e-488c-49d4-8432-98db855962e9 | 102 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 08efb26e-488c-49d4-8432-98db855962e9 | 102 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | b07c0a91-892c-47f5-819e-a128e0ef1ed7 | 101 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | b07c0a91-892c-47f5-819e-a128e0ef1ed7 | 101 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | b07c0a91-892c-47f5-819e-a128e0ef1ed7 | 101 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f | 100 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f | 100 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f | 100 |
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 11 |
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 3 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 3 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 3 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68382-623-01 | 68382062301 | 100 TABLET in 1 BOTTLE (68382-623-01) | 100 tablet | 2023-03-21 | No | No | Current |
| 68382-623-05 | 68382062305 | 500 TABLET in 1 BOTTLE (68382-623-05) | 500 tablet | 2023-03-21 | No | No | Current |
| 68382-623-10 | 68382062310 | 1000 TABLET in 1 BOTTLE (68382-623-10) | 1000 tablet | 2023-03-21 | No | No | Current |
| 68382-623-30 | 68382062330 | 100 BLISTER PACK in 1 CARTON (68382-623-30) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2023-03-21 | No | No | Current |