Home NDC 0409-3213 Diazepam
Product NDC 0409-3213
11-digit product format 004093213
Labeler code 0409
Product ID 0409-3213_54805cd5-8b81-402d-bb07-ffb5293222b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA071583
Marketing category ANDA
Marketing start 2007-10-05
Substance DIAZEPAM
Active strength 5 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-3213-02 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-3213-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-3213-02 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-3213-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-3213-02 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-3213-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-3213-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-3213-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-3213-02 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-3213-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-3213-02 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-3213-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-3213-02 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-3213-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-3213-02 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-3213-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-3213-02 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-3213-10 0efc9e666f02…f202fb6c5f17…
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 A071583-001 DIAZEPAM DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071583-001 AP
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 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 5 mg/mL
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 309845 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 0409-3213-11 Diazepam 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 26 0409-3213-12 Diazepam 10 in 1 BOX INJECTION, SOLUTION 10 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIAZEPAM ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 DIAZEPAM ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 12 Diazepam ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.] 3 Diazepam ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.] 3 Diazepam ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 DIAZEPAM ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 DIAZEPAM ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 Diazepam ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 DIAZEPAM ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 DIAZEPAM ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 Benzoic Acid INACTIVE INGREDIENT 8SKN0B0MIM DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-3213 DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 25 Current NDC, Legacy NDC, 2 package rows 20241220_7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM Hospira, Inc. 7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583 ndc (product): 0409-3213 Diazepam DIAZEPAM Henry Schein, Inc. bfa85a63-967f-4176-a752-0bafabbaaae3 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583 Diazepam DIAZEPAM Medical Purchasing Solutions, LLC c8e979a8-af6b-f0c4-e053-2995a90ae63f 2023-05-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583
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 0409-3213-11 00409321311 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 0409-3213-12 00409321312 10 VIAL, MULTI-DOSE in 1 BOX (0409-3213-12) / 10 mL in 1 VIAL, MULTI-DOSE (0409-3213-11) 2007-10-05 0000-00-00 No No Current