Home NDC 75907-028 Estazolam
Product NDC 75907-028
11-digit product format 759070028
Labeler code 75907
Product ID 75907-028_72da6d6d-2d81-d7a4-6454-2b8967981fea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estazolam
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Labratories Inc.
Application ANDA074921
Marketing category ANDA
Marketing start 2024-02-15
Substance ESTAZOLAM
Active strength 1 mg/1
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Estazolam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTAZOLAM 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 36S3EQV54C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197653 Internal RxNorm lookup 197654 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 75907-028-01 Estazolam 100 in 1 BOTTLE, PLASTIC TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-028 ESTAZOLAM TABLET [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 1 package rows 20240215_2f349a44-6d04-01d1-c8b7-12254aead77d.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 75907-028-01 75907002801 100 TABLET in 1 BOTTLE, PLASTIC (75907-028-01) 100 tablet 2024-02-15 No No Current