Home NDC 69339-201 Alprazolam
Product NDC 69339-201
11-digit product format 693390201
Labeler code 69339
Product ID 69339-201_885d0fec-f1a6-42f4-8617-1d048cb15ee9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler Natco Pharma USA LLC
Application ANDA200739
Marketing category ANDA
Marketing start 2023-07-28
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 43 .
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 A200739-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 A200739-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 A200739-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 A200739-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15
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.
Product history page 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197321 Internal RxNorm lookup 197322 Internal RxNorm lookup 308047 Internal RxNorm lookup 308048 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 69339-201-01 Alprazolam 100 in 1 BOTTLE TABLET 100 3 69339-201-05 Alprazolam 500 in 1 BOTTLE TABLET 500 3 69339-201-10 Alprazolam 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-201 ALPRAZOLAM TABLET [NATCO PHARMA USA LLC] 2 Current NDC, 3 package rows 20231103_b3c55877-2538-4892-bdb1-d618c643d29c.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 · 1 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 69339-201-01 69339020101 100 TABLET in 1 BOTTLE (69339-201-01) 100 tablet 2023-07-28 No No Current 69339-201-05 69339020105 500 TABLET in 1 BOTTLE (69339-201-05) 500 tablet 2023-07-28 No No Current 69339-201-10 69339020110 1000 TABLET in 1 BOTTLE (69339-201-10) 1000 tablet 2023-07-28 No No Current