Diazepam

Product NDC
70518-0162
11-digit product format
705180162
Labeler code
70518
Product ID
70518-0162_4b1e1881-5865-403c-e063-6294a90af3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071322
Marketing category
ANDA
Marketing start
2017-01-23
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-016270518-0162-1DDiscontinued by firm2026-08-10
excluded packagepackage70518-016270518-0162-3DDiscontinued by firm2026-08-10
excluded packagepackage70518-016270518-0162-4DDiscontinued by firm2026-08-10

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-0162-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-0162-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-0162-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-0162-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-0162-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-0162-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-0162-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-0162-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-0162-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-0162-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-0162-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-0162-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-0162-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-0162-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-0162-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-0162-1557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071322-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1986-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071322-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071322-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3JTX2Q7TUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197589Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ebef149-1858-4199-aaed-7b9341fae63dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0162-0Diazepam30 in 1 BLISTER PACKTABLET3024
70518-0162-1Diazepam100 in 1 BOXTABLET10024
70518-0162-2Diazepam1 in 1 POUCHTABLET124
70518-0162-3Diazepam2 in 1 BOTTLE, PLASTICTABLET224
70518-0162-4Diazepam30 in 1 BOTTLE, PLASTICTABLET3024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0162DIAZEPAM TABLET [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 5 package rows20250529_5ebef149-1858-4199-aaed-7b9341fae63d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMREMEDYREPACK INC.5ebef149-1858-4199-aaed-7b9341fae63d2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 70518-0162
DiazepamDIAZEPAMCoupler LLC5111654f-a026-71b2-e063-6294a90ab49b2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.84cecab3-d0e6-436b-996b-0b598e9723082025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb7002d26-3856-4c2f-e053-2995a90aea602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.859461ea-5861-8185-e053-2991aa0a954a2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMBryant Ranch Prepack078bbb41-7e3a-48db-87f0-ec6a6ec0194e2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLC9cf031ae-d59b-430d-9b15-415ae2e49c982022-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMProficient Rx LPf8d26f65-a015-4bfc-b1fa-8595d72af48c2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN5ebef149-1858-4199-aaed-7b9341fae63d24
197589diazepam 10 MG Oral TabletSCD5ebef149-1858-4199-aaed-7b9341fae63d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0162-07051801620030 TABLET in 1 BLISTER PACK (70518-0162-0) 30 tablet2017-01-230000-00-00NoNoCurrent
70518-0162-170518016201100 POUCH in 1 BOX (70518-0162-1) > 1 TABLET in 1 POUCH (70518-0162-2) 100 pouch2020-01-160000-00-00NoNoCurrent
70518-0162-2705180162021 in 1 POUCHHistorical
70518-0162-3705180162032 TABLET in 1 BOTTLE, PLASTIC (70518-0162-3) 2 tablet2021-05-280000-00-00NoNoCurrent
70518-0162-47051801620430 in 1 BOTTLE, PLASTICHistorical