Home NDC 49884-725 Buspirone Hydrochloride
Product NDC 49884-725
11-digit product format 498840725
Labeler code 49884
Product ID 49884-725_50252037-c222-4d3f-8d09-38781bbd2df6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA075467
Marketing category ANDA
Marketing start 2012-04-23
Marketing end 2022-08-31
Substance BUSPIRONE HYDROCHLORIDE
Active strength 8 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075467-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 A075467-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 A075467-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 A075467-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28
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.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075467-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075467-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075467-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075467-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-02-28 d06236e962d9…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.] 3 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-725-01 49884072501 100 TABLET in 1 BOTTLE (49884-725-01) 100 tablet 2012-04-23 2022-08-31 No No Current 49884-725-05 49884072505 500 TABLET in 1 BOTTLE (49884-725-05) 500 tablet 2012-04-23 2022-08-31 No No Current