Home NDC 53002-3950-3 Alprazolam
Product NDC 53002-3950
Requested package NDC 53002-3950-3
11-digit product format 530023950
Labeler code 53002
Product ID 53002-3950_9ce63d54-65b7-45e6-bc26-5d1587d8c255
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA200739
Marketing category ANDA
Marketing start 2015-10-01
Marketing end 0000-00-00
Substance ALPRAZOLAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2021-12-31
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 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 168 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-3950-1 Alprazolam 10 in 1 BOTTLE TABLET 10 4 53002-3950-2 Alprazolam 20 in 1 BOTTLE TABLET 20 4 53002-3950-3 Alprazolam 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-3950 ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.] 4 Legacy NDC, 3 package rows 20201217_81e74e77-398a-45db-a8df-a59bee5c97ad.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alprazolam ALPRAZOLAM Natco Pharma USA LLC b3c55877-2538-4892-bdb1-d618c643d29c 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200739 application number: ANDA200739
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 53002-3950-3 53002395003 30 TABLET in 1 BOTTLE (53002-3950-3) 30 tablet 2017-10-01 0000-00-00 No No Current