BUSPIRONE HYDROCHLORIDE
- Product NDC
- 70518-4317
- Requested package NDC
- 70518-4317-0
- 11-digit product format
- 705184317
- Labeler code
- 70518
- Product ID
- 70518-4317_5aa99494-571a-ac36-e063-6394a90a8a0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUSPIRONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078246
- Marketing category
- ANDA
- Marketing start
- 2025-03-21
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 7.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078246-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | |
| A078246-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | |
| A078246-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | |
| A078246-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | |
| A078246-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078246-001 | AB |
| A078246-002 | AB |
| A078246-003 | AB |
| A078246-004 | AB |
| A078246-005 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2009-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2009-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2009-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078246-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078246-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078246-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078246-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078246-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078246-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078246-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078246-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078246-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078246-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078246-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078246-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078246-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078246-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078246-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078246-005 | AB | 1 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUSPIRONE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 207LT9J9OC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 866111 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fa4d5cac-f687-4440-99d2-8bb27cf2f4ed | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 70518-4317-0 | BUSPIRONE HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-4317 | BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250323_fa4d5cac-f687-4440-99d2-8bb27cf2f4ed.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fa4d5cac-f687-4440-99d2-8bb27cf2f4ed | 2026-09-04 | Warnings, Adverse reactions | 078246 ANDA078246 70518-4317-0 70518-4317 70518431700 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | fc0f93c8-2078-b2ff-e053-6294a90aacdf | 2024-12-31 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 529ab1f9-534c-4a45-aa70-76e605247af1 | 2024-12-03 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 75b1ae3f-e926-4555-a0e9-50323fc66cb2 | 2024-02-01 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 55e32128-711d-4e95-b58b-e86e0afa4983 | 2023-12-05 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | d47cde56-e1ab-41fe-832e-d3f33b884a5e | 2023-11-28 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 501b0406-f56e-44d3-906a-7625b936f075 | 2023-11-01 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 2bc87b32-bdb7-4ce6-8a51-aed623f7219e | 2023-06-05 | Warnings, Adverse reactions | 078246 ANDA078246 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | 05c006d2-44b9-431f-bce2-aff09c043ecb | 2021-07-05 | Warnings, Adverse reactions | 078246 ANDA078246 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | fa4d5cac-f687-4440-99d2-8bb27cf2f4ed | 2 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | fa4d5cac-f687-4440-99d2-8bb27cf2f4ed | 2 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | fa4d5cac-f687-4440-99d2-8bb27cf2f4ed | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4317-0 | 70518431700 | 30 TABLET in 1 BLISTER PACK (70518-4317-0) | 30 tablet | 2025-03-21 | No | No | Current |