Home NDC 64980-627 Lorazepam
Product NDC 64980-627
11-digit product format 649800627
Labeler code 64980
Product ID 64980-627_b47aeb6e-aa7a-469b-a709-15df0e99ea79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA218597
Marketing category ANDA
Marketing start 2025-07-24
Substance LORAZEPAM
Active strength .5 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 42 .
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 A218597-001 LORAZEPAM LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 A218597-002 LORAZEPAM LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 A218597-003 LORAZEPAM LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24
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.
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 A218597-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218597-002 LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218597-003 LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218597-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218597-002 LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218597-003 LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218597-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218597-002 LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218597-003 LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218597-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218597-002 LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218597-003 LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218597-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2025-07-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218597-002 LORAZEPAM 1MG TABLET / ORAL AB 2025-07-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218597-003 LORAZEPAM 2MG TABLET / ORAL AB 2025-07-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lorazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORAZEPAM .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O26FZP769L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197900 Internal RxNorm lookup 197901 Internal RxNorm lookup 197902 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 64980-627-01 Lorazepam 100 in 1 BOTTLE TABLET 100 1 64980-627-10 Lorazepam 1000 in 1 BOTTLE TABLET 1000 1 64980-627-50 Lorazepam 500 in 1 BOTTLE TABLET 500 1
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 · 3 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 64980-627-01 64980062701 100 TABLET in 1 BOTTLE (64980-627-01) 100 tablet 2025-07-24 No No Current 64980-627-10 64980062710 1000 TABLET in 1 BOTTLE (64980-627-10) 1000 tablet 2025-07-24 No No Current 64980-627-50 64980062750 500 TABLET in 1 BOTTLE (64980-627-50) 500 tablet 2025-07-24 No No Current