Buspirone Hydrochloride
- Product NDC
- 0378-1145
- 11-digit product format
- 003781145
- Labeler code
- 0378
- Product ID
- 0378-1145_d6848975-7bf9-4227-a73c-2631d8b050be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076008
- Marketing category
- ANDA
- Marketing start
- 2013-07-08
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 8 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 0378-1145-01 | Buspirone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-1145-01 | EA - Each | 0378-1145 | 081900c5-1d31-450f-b112-3362a5850403 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | ACTIVE INGREDIENT | 207LT9J9OC | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| BUSPIRONE | ACTIVE MOIETY | TK65WKS8HL | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 22 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | ea4fc29e-35f6-43ca-aeb1-f323b2d926f9 | 1 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | ea4fc29e-35f6-43ca-aeb1-f323b2d926f9 | 1 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | ea4fc29e-35f6-43ca-aeb1-f323b2d926f9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-1145-01 | 00378114501 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) | 100 tablet | 2013-07-31 | 0000-00-00 | No | No | Current |