Home NDC 13107-320-01 CLORAZEPATE DIPOTASSIUM
Product NDC 13107-320
Requested package NDC 13107-320-01
11-digit product format 131070320
Labeler code 13107
Product ID 13107-320_5da093d0-dc77-4240-97f1-d1e0ccc622ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLORAZEPATE DIPOTASSIUM
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma LLC
Application ANDA071858
Marketing category ANDA
Marketing start 1987-07-17
Marketing end 2027-02-28
Substance CLORAZEPATE DIPOTASSIUM
Active strength 7.5 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Current FDA listing Yes 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 · 1 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 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13107-320 13107-320-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071858-001 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 A071858-002 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 A071858-003 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CLORAZEPATE DIPOTASSIUM Active Ingredients# Ingredient, Strength table Ingredient Strength CLORAZEPATE DIPOTASSIUM 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63FN7G03XY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197464 Internal RxNorm lookup 197465 Internal RxNorm lookup 197466 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 13107-320-01 CLORAZEPATE DIPOTASSIUM 100 in 1 BOTTLE, PLASTIC TABLET 100 5 13107-320-05 CLORAZEPATE DIPOTASSIUM 500 in 1 BOTTLE, PLASTIC TABLET 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-320 CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250117_919cbd07-f587-4005-acff-26213dd1d1fb.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 · 2 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 13107-320-01 13107032001 100 TABLET in 1 BOTTLE, PLASTIC (13107-320-01) 100 tablet 1987-07-17 2027-02-28 No No Current