Home NDC 0054-3068 Alprazolam
Product NDC 0054-3068
11-digit product format 000543068
Labeler code 0054
Product ID 0054-3068_d7b8cdff-1337-4ef6-a5fb-654f1d655bfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074312
Marketing category ANDA
Marketing start 1993-10-31
Substance ALPRAZOLAM
Active strength 1 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074312-001 ALPRAZOLAM ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074312-001 ALPRAZOLAM 1MG/ML CONCENTRATE / ORAL RS 1993-10-31 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Alprazolam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALPRAZOLAM 1 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308050 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 0054-3068-44 Alprazolam 30 mL in 1 BOTTLE SOLUTION, CONCENTRATE 30 13 0054-3068-44 Alprazolam 1 in 1 CONTAINER SOLUTION, CONCENTRATE 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALPRAZOLAM ACTIVE INGREDIENT YU55MQ3IZY ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 8 ALPRAZOLAM ACTIVE MOIETY YU55MQ3IZY ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 8 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3068 ALPRAZOLAM SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20241115_b945ac6f-796e-41ef-85e9-61007e4a4e9a.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 Marketing end Sample Exclude flag Status 0054-3068-44 00054306844 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE 1 bottle 1993-10-31 0000-00-00 No No Current