Diazepam

Product NDC
51079-284
11-digit product format
510790284
Labeler code
51079
Product ID
51079-284_3a39f676-7a52-3d33-e063-6294a90a4123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070325
Marketing category
ANDA
Marketing start
1997-10-31
Substance
DIAZEPAM
Active strength
2 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070325-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1985-09-04
A070325-002DIAZEPAMDIAZEPAM2MGTABLET / ORALAB1985-09-04
A070325-003DIAZEPAMDIAZEPAM5MGTABLET / ORALAB1985-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A070325-001AB
A070325-002AB
A070325-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070325-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM2 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197589Internal RxNorm lookup
197590Internal RxNorm lookup
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
b326c66d-5762-4d16-933c-619fa2088ccdAvailable 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
51079-284-01Diazepam1 in 1 BLISTER PACKTABLET118
51079-284-20Diazepam100 in 1 CARTONTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-284-01EA - Each51079-2845a21e470-357c-4ce0-8908-598847b8391312012-07-24
51079-284-20EA - Each51079-284b241accc-c7a7-4424-ac8e-a33db2e433dd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-284DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]17Current NDC, Legacy NDC, 2 package rows20240919_b326c66d-5762-4d16-933c-619fa2088ccd.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.6dcbb5e9-1e8f-4069-9244-adb46356714d2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.7646785b-dabc-482d-bf42-06177f00aca22026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMSafecor Health, LLC8b51f4b3-a5e8-4400-b624-ac0c47630c862026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_Rx181cc7ac-5129-2200-e063-6394a90afd3a2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMA-S Medication Solutions01f04ee4-fff9-499a-8213-984e163680842025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.c2768add-5e01-4ff4-afa3-230380d59a1f2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMMylan Institutional Inc.b326c66d-5762-4d16-933c-619fa2088ccd2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 51079-284
DiazepamDIAZEPAMAdvanced Rx of Tennessee, LLC2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepack9424ce71-f04c-4d70-89de-b7858931c53d2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepack632d7e96-d32c-45b8-86cf-f18ec2b354852024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_rx2047f721-6a05-c391-e063-6394a90a4ed72024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepackf2fc6f38-d627-4fb3-9be2-5e119ee7e1e12023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMMylan Pharmaceuticals Inc.c397a9da-862f-4f3f-8109-7d21691de53a2023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197590diazePAM 2 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197591diazePAM 5 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197589diazepam 10 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18
197590diazepam 2 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18
197591diazepam 5 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-284-01510790284011 in 1 BLISTER PACKHistorical
51079-284-2051079028420100 BLISTER PACK in 1 CARTON (51079-284-20) / 1 TABLET in 1 BLISTER PACK (51079-284-01) 100 blister pack1997-10-310000-00-00NoNoCurrent