Diazepam

Product NDC
55154-5074
11-digit product format
551545074
Labeler code
55154
Product ID
55154-5074_c55f220e-6302-450a-845a-f7780e22b97e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA070325
Marketing category
ANDA
Marketing start
2009-11-20
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

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
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197589Internal 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
ba953b22-f0cd-4be5-9e0e-178bded88727Available 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
55154-5074-0Diazepam10 in 1 BAGTABLET1018
55154-5074-0Diazepam1 in 1 BLISTER PACKTABLET118

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [CARDINAL HEALTH]8
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [CARDINAL HEALTH]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [CARDINAL HEALTH]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [CARDINAL HEALTH]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [CARDINAL HEALTH]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5074DIAZEPAM TABLET [CARDINAL HEALTH 107, LLC]16Current NDC, Legacy NDC, 2 package rows20241226_ba953b22-f0cd-4be5-9e0e-178bded88727.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
ndc (product): 55154-5074
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
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 TabletPSNba953b22-f0cd-4be5-9e0e-178bded8872718
197591diazePAM 5 MG Oral TabletPSNba953b22-f0cd-4be5-9e0e-178bded8872718
197589diazepam 10 MG Oral TabletSCDba953b22-f0cd-4be5-9e0e-178bded8872718
197591diazepam 5 MG Oral TabletSCDba953b22-f0cd-4be5-9e0e-178bded8872718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5074-05515450740010 BLISTER PACK in 1 BAG (55154-5074-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2009-11-200000-00-00NoNoCurrent