Home NDC 11534-199 DIAZEPAM
Product NDC 11534-199
11-digit product format 115340199
Labeler code 11534
Product ID 11534-199_e95b8ea6-9d51-4621-bb87-a365121b08bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazepam
Dosage form TABLET
Route ORAL
Labeler Sunrise Pharmaceutical, Inc.
Application ANDA070464
Marketing category ANDA
Marketing start 2024-12-09
Substance DIAZEPAM
Active strength 10 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070464-001 DIAZEPAM DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 A070464-002 DIAZEPAM DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 A070464-003 DIAZEPAM DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10
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 2 · 63 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 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DIAZEPAM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3JTX2Q7TU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197589 Internal RxNorm lookup 197590 Internal RxNorm lookup 197591 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 11534-199-01 DIAZEPAM 100 in 1 BOTTLE TABLET 100 7 11534-199-03 DIAZEPAM 1000 in 1 BOTTLE TABLET 1000 7 11534-199-04 DIAZEPAM 500 in 1 BOTTLE TABLET 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11534-199 DIAZEPAM TABLET [SUNRISE PHARMACEUTICAL, INC.] 7 Current NDC, 3 package rows 20241211_34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8.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 11534-199-01 11534019901 100 TABLET in 1 BOTTLE (11534-199-01) 100 tablet 2024-12-10 No No Current 11534-199-03 11534019903 1000 TABLET in 1 BOTTLE (11534-199-03) 1000 tablet 2024-12-10 No No Current 11534-199-04 11534019904 500 TABLET in 1 BOTTLE (11534-199-04) 500 tablet 2024-12-10 No No Current