Home NDC 0121-0905 Diazepam
Product NDC 0121-0905
11-digit product format 001210905
Labeler code 0121
Product ID 0121-0905_cc0d49f5-c681-9d48-e053-2a95a90a597b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form SOLUTION
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA070928
Marketing category ANDA
Marketing start 1987-04-03
Substance DIAZEPAM
Active strength 5 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070928-001 DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070928-001 AA
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 · 41 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 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070928-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA RS 1987-04-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 5 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309843 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 0121-0905-05 Diazepam 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 2 0121-0905-94 Diazepam 3 in 1 CASE SOLUTION 3 2 0121-0905-94 Diazepam 10 in 1 TRAY SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0905 DIAZEPAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20210917_b24f1eb7-3dab-4183-b81f-f86ac62aedd8.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM Precision Dose Inc. 78d5a77d-5ca7-4f16-b4d0-fce86456593c 2025-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070928 application number: ANDA070928 Diazepam DIAZEPAM Hikma Pharmaceuticals USA Inc. 9e85abed-1a8b-4762-a31f-f2c7f196b8af 2024-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070928 application number: ANDA070928 Diazepam DIAZEPAM American Health Packaging aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded 2023-08-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070928 application number: ANDA070928 Diazepam DIAZEPAM Pharmaceutical Associates, Inc. b24f1eb7-3dab-4183-b81f-f86ac62aedd8 2021-09-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070928 application number: ANDA070928 ndc (product): 0121-0905
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 0121-0905-05 00121090505 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-0905-94 00121090594 3 TRAY in 1 CASE (0121-0905-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05) 3 tray 2021-02-26 0000-00-00 No No Current