Home NDC 29300-362-05 Alprazolam
Product NDC 29300-362
Requested package NDC 29300-362-05
11-digit product format 293000362
Labeler code 29300
Product ID 29300-362_a806e27a-19e4-4780-b622-d9c9a062b37f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA213204
Marketing category ANDA
Marketing start 2026-11-02
Substance ALPRAZOLAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
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 44 .
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 A213204-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL AB 2026-07-13 A213204-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL AB 2026-07-13 A213204-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL AB 2026-07-13 A213204-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 2026-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 2026-10-15 13:18:30 2026-09 A213204-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213204-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213204-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213204-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2026-07-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213204-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213204-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213204-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213204-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213204-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213204-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213204-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213204-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2026-07-13 caaa826d4ba7…
Observed Orange Book normalized TE history# 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 Alprazolam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALPRAZOLAM 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YU55MQ3IZY Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 29300-362-05 29300036205 500 TABLET in 1 BOTTLE (29300-362-05) 500 tablet 2026-11-02 No No Current