Home NDC 69339-136 Diazepam
Product NDC 69339-136
11-digit product format 693390136
Labeler code 69339
Product ID 69339-136_169f5115-24f1-4e7e-8981-5df941ce087d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Natco Pharma USA LLC
Application ANDA210363
Marketing category ANDA
Marketing start 2019-03-22
Substance DIAZEPAM
Active strength 10 mg/2mL
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A210363-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210363-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2019-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION RS 2019-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION RS 2019-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION RS 2019-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION RS 2019-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2019-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2019-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2019-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210363-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP RS 2019-03-18 e64feba35796…
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 10 mg/2mL
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 2120550 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 69339-136-02 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 7 69339-136-03 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 7 69339-136-32 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 7 69339-136-34 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 7 69339-136-93 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 2 69339-136-97 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-136 DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250302_6b8dc373-fa01-42c9-89af-4e00bf00180a.zip 69339-136 DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20250429_a14f5930-a3ac-4996-9778-df5baa3d0bab.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 REMEDYREPACK INC. c57af2a2-aa9a-4dac-a200-e0d845005d05 2026-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210363 application number: ANDA210363 Diazepam DIAZEPAM Natco Pharma USA LLC 6b8dc373-fa01-42c9-89af-4e00bf00180a 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 69339-136 Diazepam DIAZEPAM Natco Pharma USA LLC a14f5930-a3ac-4996-9778-df5baa3d0bab 2025-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (product): 69339-136 Diazepam DIAZEPAM Civica, Inc. 83646a0f-eb43-4871-b95e-683c2533d2be 2025-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210363 application number: ANDA210363
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 69339-136-02 69339013602 2 mL in 1 SYRINGE, GLASS 2 ml Historical 69339-136-03 69339013603 2 mL in 1 SYRINGE, GLASS 2 ml Historical 69339-136-32 69339013632 10 SYRINGE, GLASS in 1 CARTON (69339-136-32) > 2 mL in 1 SYRINGE, GLASS (69339-136-02) 2019-03-22 2022-09-30 No No Current 69339-136-34 69339013634 10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) 2021-04-01 0000-00-00 No No Current 69339-136-93 69339013693 2 mL in 1 SYRINGE, GLASS 2 ml Historical 69339-136-97 69339013697 10 SYRINGE, GLASS in 1 CARTON (69339-136-97) / 2 mL in 1 SYRINGE, GLASS (69339-136-93) 2025-05-01 No No Current