FDA.reportPublic FDA data

Diazepam

Product NDC
0378-0477
11-digit product format
003780477
Labeler code
0378
Product ID
0378-0477_983a3fdc-04ca-4621-a57c-56ad36015d36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070325
Marketing category
ANDA
Marketing start
1985-09-04
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

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 Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 197590, 197591

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
0378-0477-01Diazepam100 in 1 BOTTLE, PLASTICTABLET10015
0378-0477-05Diazepam500 in 1 BOTTLE, PLASTICTABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0477-01EA - Each0378-04774e92e6cd-10b4-4424-bf46-a97f43dcba9d12012-07-24
0378-0477-05EA - Each0378-0477a38c7da1-e75f-4e17-aa5c-1bfcd1af87e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [STAT RX USA LLC]3
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [STAT RX USA LLC]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [STAT RX USA LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [STAT RX USA LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [STAT RX USA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [STAT RX USA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [STAT RX USA LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [STAT RX USA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0477DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20240328_c397a9da-862f-4f3f-8109-7d21691de53a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNf2fc6f38-d627-4fb3-9be2-5e119ee7e1e1100
197589diazepam 10 MG Oral TabletSCDf2fc6f38-d627-4fb3-9be2-5e119ee7e1e1100
197589diazePAM 10 MG Oral TabletPSNc2768add-5e01-4ff4-afa3-230380d59a1f19
197589diazepam 10 MG Oral TabletSCDc2768add-5e01-4ff4-afa3-230380d59a1f19
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
197589diazePAM 10 MG Oral TabletPSNc397a9da-862f-4f3f-8109-7d21691de53a15
197590diazePAM 2 MG Oral TabletPSNc397a9da-862f-4f3f-8109-7d21691de53a15
197591diazePAM 5 MG Oral TabletPSNc397a9da-862f-4f3f-8109-7d21691de53a15
197589diazepam 10 MG Oral TabletSCDc397a9da-862f-4f3f-8109-7d21691de53a15
197590diazepam 2 MG Oral TabletSCDc397a9da-862f-4f3f-8109-7d21691de53a15
197591diazepam 5 MG Oral TabletSCDc397a9da-862f-4f3f-8109-7d21691de53a15
197589diazePAM 10 MG Oral TabletPSN6dcbb5e9-1e8f-4069-9244-adb46356714d4
197589diazePAM 10 MG Oral TabletPSN181cc7ac-5129-2200-e063-6394a90afd3a4
197589diazepam 10 MG Oral TabletSCD181cc7ac-5129-2200-e063-6394a90afd3a4
197589diazepam 10 MG Oral TabletSCD6dcbb5e9-1e8f-4069-9244-adb46356714d4
197589diazePAM 10 MG Oral TabletPSN66ea2936-8b6c-4b72-b077-ecf88e83fee73
197591diazePAM 5 MG Oral TabletPSN66ea2936-8b6c-4b72-b077-ecf88e83fee73
197589diazepam 10 MG Oral TabletSCD66ea2936-8b6c-4b72-b077-ecf88e83fee73
197591diazepam 5 MG Oral TabletSCD66ea2936-8b6c-4b72-b077-ecf88e83fee73
197589diazePAM 10 MG Oral TabletPSN2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2
197589diazePAM 10 MG Oral TabletPSN8b51f4b3-a5e8-4400-b624-ac0c47630c862
197589diazePAM 10 MG Oral TabletPSN8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32
197590diazePAM 2 MG Oral TabletPSN8b51f4b3-a5e8-4400-b624-ac0c47630c862
197591diazePAM 5 MG Oral TabletPSN2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2
197591diazePAM 5 MG Oral TabletPSN8b51f4b3-a5e8-4400-b624-ac0c47630c862
197589diazepam 10 MG Oral TabletSCD8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32
197589diazepam 10 MG Oral TabletSCD2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2
197589diazepam 10 MG Oral TabletSCD8b51f4b3-a5e8-4400-b624-ac0c47630c862
197590diazepam 2 MG Oral TabletSCD8b51f4b3-a5e8-4400-b624-ac0c47630c862
197591diazepam 5 MG Oral TabletSCD2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2
197591diazepam 5 MG Oral TabletSCD8b51f4b3-a5e8-4400-b624-ac0c47630c862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0477-0100378047701100 TABLET in 1 BOTTLE, PLASTIC (0378-0477-01) 100 tablet1985-09-040000-00-00NoNoCurrent
0378-0477-0500378047705500 TABLET in 1 BOTTLE, PLASTIC (0378-0477-05) 500 tablet1985-09-040000-00-00NoNoCurrent