BusPIRone Hydrochloride
- Product NDC
- 49252-099
- 11-digit product format
- 492520099
- Labeler code
- 49252
- Product ID
- 49252-099_c6b7fc59-fce9-4475-aa11-ac673859fd7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BusPIRone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Inventia Healthcare Private Limited
- Application
- ANDA209696
- Marketing category
- ANDA
- Marketing start
- 2018-05-16
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 49252-099-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012f-f424-e053-dadaa90a57ce | Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) |
| 49252-099-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012f-f424-e053-dadaa90a57ce | Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) |
| 49252-099-17 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012f-f424-e053-dadaa90a57ce | Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) |
| 49252-099-18 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012f-f424-e053-dadaa90a57ce | Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) |
| 49252-099-57 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012f-f424-e053-dadaa90a57ce | Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49252-099-11 | BusPIRone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 49252-099-13 | BusPIRone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 49252-099-17 | BusPIRone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 49252-099-18 | BusPIRone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 49252-099-54 | BusPIRone Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 49252-099-57 | BusPIRone Hydrochloride | 10 in 1 CARTON | TABLET | 10 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 3c543c3d-109c-455c-91fb-277ef77cabad | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 49252-099-11 | 49252009911 | 60 in 1 BOTTLE | Historical |
| 49252-099-13 | 49252009913 | 100 in 1 BOTTLE | Historical |
| 49252-099-17 | 49252009917 | 500 in 1 BOTTLE | Historical |
| 49252-099-18 | 49252009918 | 1000 in 1 BOTTLE | Historical |
| 49252-099-54 | 49252009954 | 10 in 1 BLISTER PACK | Historical |
| 49252-099-57 | 49252009957 | 10 in 1 CARTON | Historical |