Diazepam

Product NDC
63187-173
11-digit product format
631870173
Labeler code
63187
Product ID
63187-173_0471cce6-7ddc-4530-a794-3da0d7fd94d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071321
Marketing category
ANDA
Marketing start
1986-12-10
Substance
DIAZEPAM
Active strength
5 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071321-001DIAZEPAMDIAZEPAM5MGTABLET / 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
A071321-001AB

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 UTC2026-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071321-001DIAZEPAM5MGTABLET / 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 UTC2026-02A071321-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071321-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071321-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 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
197591Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7542d46-2586-4225-b07d-2633116bfa0aAvailable 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
63187-173-01Diazepam1 in 1 BOTTLETABLET19
63187-173-02Diazepam2 in 1 BOTTLETABLET29
63187-173-10Diazepam10 in 1 BOTTLETABLET109
63187-173-15Diazepam15 in 1 BOTTLETABLET159
63187-173-20Diazepam20 in 1 BOTTLETABLET209
63187-173-21Diazepam21 in 1 BOTTLETABLET219
63187-173-30Diazepam30 in 1 BOTTLETABLET309
63187-173-60Diazepam60 in 1 BOTTLETABLET609
63187-173-90Diazepam90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-173-01EA - Each63187-173d42a4fa1-9df3-48ef-8401-b9aaad167e0812022-03-09
63187-173-10EA - Each63187-1736c26cc09-46aa-438a-ae22-7a213e9406f412023-08-08
63187-173-15EA - Each63187-1738d1dc537-8c1f-46fc-8499-545dad91c8a812023-08-08
63187-173-30EA - Each63187-173d164c037-0380-4367-a9e3-7f4d05c1f43912023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PROFICIENT RX LP]2
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PROFICIENT RX LP]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIAZEPAM TABLET [PROFICIENT RX LP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-173DIAZEPAM TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 9 package rows20220504_e7542d46-2586-4225-b07d-2633116bfa0a.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMREMEDYREPACK INC.20e08b97-bb89-4129-a228-8ad9cf35a1d32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMCoupler LLC5114ae6e-8cae-e96f-e063-6294a90a9e602026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.2483426d-3782-432a-8b8d-86c06ef0de4a2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.823093aa-d0cd-53c9-e053-2a91aa0a52352024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.8b3cc5c9-91bd-7467-e053-2a95a90a44b82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMBryant Ranch Prepack6abedac6-5133-47b2-a0e3-e239e0a2254b2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMBryant Ranch Prepacke8e4d5f5-3b4c-4c0f-a818-9da86389473c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMA-S Medication Solutionsaf9a7906-4dca-4c1f-b16b-9b666a86b3632024-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC87b0fbb9-0c05-4ab0-8efe-7ffcae85b8682024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMProficient Rx LPe7542d46-2586-4225-b07d-2633116bfa0a2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 63187-173
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCbdb8feda-01c6-45bd-bd66-97196ccce70c2019-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSNe7542d46-2586-4225-b07d-2633116bfa0a9
197591diazepam 5 MG Oral TabletSCDe7542d46-2586-4225-b07d-2633116bfa0a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-173-01631870173011 TABLET in 1 BOTTLE (63187-173-01) 1 tablet2021-10-210000-00-00NoNoCurrent
63187-173-02631870173022 TABLET in 1 BOTTLE (63187-173-02) 2 tablet2018-02-010000-00-00NoNoCurrent
63187-173-106318701731010 TABLET in 1 BOTTLE (63187-173-10) 10 tablet2016-01-010000-00-00NoNoCurrent
63187-173-156318701731515 TABLET in 1 BOTTLE (63187-173-15) 15 tablet2015-09-010000-00-00NoNoCurrent
63187-173-206318701732020 TABLET in 1 BOTTLE (63187-173-20) 20 tablet2016-01-010000-00-00NoNoCurrent
63187-173-216318701732121 TABLET in 1 BOTTLE (63187-173-21) 21 tablet2018-02-010000-00-00NoNoCurrent
63187-173-306318701733030 TABLET in 1 BOTTLE (63187-173-30) 30 tablet2014-10-010000-00-00NoNoCurrent
63187-173-606318701736060 TABLET in 1 BOTTLE (63187-173-60) 60 tablet2014-10-010000-00-00NoNoCurrent
63187-173-906318701739090 TABLET in 1 BOTTLE (63187-173-90) 90 tablet2014-10-010000-00-00NoNoCurrent