Buspirone HCl
- Product NDC
- 64725-0657
- 11-digit product format
- 647250657
- Labeler code
- 64725
- Product ID
- 64725-0657_516341c3-df40-4da4-ad5b-9f54427589bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA074253
- Marketing category
- ANDA
- Marketing start
- 2001-03-28
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0657-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-391c-f424-e053-dadaa90a57ce | Revised: November 2013 Buspirone HCl Tablets USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0657-1 | Buspirone HCl | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | ACTIVE INGREDIENT | 207LT9J9OC | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| BUSPIRONE | ACTIVE MOIETY | TK65WKS8HL | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0657 | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] | 4 | Legacy NDC, 1 package rows | 20141110_ed60a885-6b02-48c8-979f-27d371e91d6e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | ed60a885-6b02-48c8-979f-27d371e91d6e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0657-1 | 64725065701 | 100 in 1 BOTTLE | Historical |