Home NDC 0591-0745 Estazolam
Product NDC 0591-0745
11-digit product format 005910745
Labeler code 0591
Product ID 0591-0745_5189e5a6-f58a-4eab-ac95-9d8011d6f3db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estazolam
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA074818
Marketing category ANDA
Marketing start 1997-10-01
Substance ESTAZOLAM
Active strength 2 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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-0745 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-0745 0591-0745-00 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-0745 0591-0745-77 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 53 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A074818-001 ESTAZOLAM ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 A074818-002 ESTAZOLAM ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19
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 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074818-001 ESTAZOLAM 1MG TABLET / ORAL AB 1997-08-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074818-002 ESTAZOLAM 2MG TABLET / ORAL AB 1997-08-19 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 2 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 0591-0745-01 Estazolam 100 in 1 BOTTLE, PLASTIC TABLET 100 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTAZOLAM ACTIVE INGREDIENT 36S3EQV54C ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 ESTAZOLAM ACTIVE MOIETY 36S3EQV54C ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] 6 ESTAZOLAM ACTIVE INGREDIENT 36S3EQV54C ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 ESTAZOLAM ACTIVE MOIETY 36S3EQV54C ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-0745 ESTAZOLAM TABLET [ACTAVIS PHARMA, INC.] 22 Current NDC, Legacy NDC, 1 package rows 20230125_a1e3b4bf-22e9-430a-a768-4d86ae886c9e.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 0591-0745-00 00591074500 66700 TABLET in 1 BAG (0591-0745-00) 66700 tablet 19-NOV-14 Current 0591-0745-01 00591074501 100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01) 100 tablet 1997-10-01 0000-00-00 No No Current 0591-0745-77 00591074577 80004 TABLET in 1 CONTAINER (0591-0745-77) 80004 tablet 31-JUL-24 Current