Home NDC 81279-122 Bucapsol
Product NDC 81279-122
11-digit product format 812790122
Labeler code 81279
Product ID 81279-122_4dc3284b-c414-6249-e063-6394a90a5d7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PANGEA PHARMACEUTICALS, LLC
Application ANDA218628
Marketing category ANDA
Marketing start 2026-04-10
Substance BUSPIRONE
Active strength 7.5 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A218628-001 BUCAPSOL BUSPIRONE HYDROCHLORIDE 7.5MG CAPSULE / ORAL 2025-03-13 A218628-002 BUCAPSOL BUSPIRONE HYDROCHLORIDE 10MG CAPSULE / ORAL 2025-03-13 A218628-003 BUCAPSOL BUSPIRONE HYDROCHLORIDE 15MG CAPSULE / ORAL RS 2025-03-13 A218628-004 BUCAPSOL BUSPIRONE HYDROCHLORIDE 5MG CAPSULE / ORAL 2026-04-29
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 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 A218628-001 BUCAPSOL 7.5MG CAPSULE / ORAL 2025-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218628-002 BUCAPSOL 10MG CAPSULE / ORAL 2025-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218628-003 BUCAPSOL 15MG CAPSULE / ORAL RS 2025-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218628-001 BUCAPSOL 7.5MG CAPSULE / ORAL 2025-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218628-002 BUCAPSOL 10MG CAPSULE / ORAL 2025-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218628-003 BUCAPSOL 15MG CAPSULE / ORAL RS 2025-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218628-001 BUSPIRONE HYDROCHLORIDE 7.5MG CAPSULE / ORAL 2025-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218628-002 BUSPIRONE HYDROCHLORIDE 10MG CAPSULE / ORAL 2025-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218628-003 BUSPIRONE HYDROCHLORIDE 15MG CAPSULE / ORAL 2025-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218628-001 BUSPIRONE HYDROCHLORIDE 7.5MG CAPSULE / ORAL 2025-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218628-002 BUSPIRONE HYDROCHLORIDE 10MG CAPSULE / ORAL 2025-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218628-003 BUSPIRONE HYDROCHLORIDE 15MG CAPSULE / ORAL 2025-03-13 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218628-001 BUCAPSOL 7.5MG CAPSULE / ORAL 2025-03-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218628-002 BUCAPSOL 10MG CAPSULE / ORAL 2025-03-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218628-003 BUCAPSOL 15MG CAPSULE / ORAL RS 2025-03-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218628-004 BUCAPSOL 5MG CAPSULE / ORAL 2026-04-29 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Bucapsol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUSPIRONE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TK65WKS8HL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2708991 Internal RxNorm lookup 2708993 Internal RxNorm lookup 2708994 Internal RxNorm lookup 2714180 Internal RxNorm lookup 2714182 Internal RxNorm lookup 2714184 Internal RxNorm lookup 2747227 Internal RxNorm lookup 2747229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81279-122-30 Bucapsol 30 in 1 BOTTLE CAPSULE 30 5 81279-122-60 Bucapsol 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81279-122 BUCAPSOL (BUSPIRONE HYDROCHLORIDE) CAPSULE [PANGEA PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250515_f101c5f3-d533-474d-a8bf-90d054933d16.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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81279-122-30 81279012230 30 CAPSULE in 1 BOTTLE (81279-122-30) 30 capsule 2026-04-10 No No Current 81279-122-60 81279012260 60 CAPSULE in 1 BOTTLE (81279-122-60) 60 capsule 2026-04-10 No No Current