Home NDC 51862-073-01 Estazolam
Product NDC 51862-073
Requested package NDC 51862-073-01
11-digit product format 518620073
Labeler code 51862
Product ID 51862-073_fc2d4f1d-8898-4fa8-858e-59d60daca9e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estazolam
Dosage form TABLET
Route ORAL
Labeler Mayne Pharma
Application ANDA074921
Marketing category ANDA
Marketing start 2020-10-18
Marketing end 0000-00-00
Substance ESTAZOLAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2024-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51862-073 51862-073-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51862-073 51862-073-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074921-001 ESTAZOLAM ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 A074921-002 ESTAZOLAM ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074921-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-07-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074921-002 ESTAZOLAM 2MG TABLET / ORAL AB RS 1997-07-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 Estazolam ESTAZOLAM Dr. Reddy's Labratories Inc. 2f349a44-6d04-01d1-c8b7-12254aead77d 2024-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074921 application number: ANDA074921
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51862-073-01 51862007301 100 TABLET in 1 BOTTLE, PLASTIC (51862-073-01) 100 tablet 2020-10-18 0000-00-00 No No Current