FDA.reportPublic FDA data

Diazepam

Product NDC
55289-092
11-digit product format
552890092
Labeler code
55289
Product ID
55289-092_4199c273-a07c-ebb6-e063-6394a90a77a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589

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
55289-092-01Diazepam100 in 1 BOTTLE, PLASTICTABLET10019
55289-092-02Diazepam2 in 1 BOTTLE, PLASTICTABLET219
55289-092-06Diazepam6 in 1 BOTTLE, PLASTICTABLET619
55289-092-10Diazepam10 in 1 BOTTLE, PLASTICTABLET1019
55289-092-20Diazepam20 in 1 BOTTLE, PLASTICTABLET2019
55289-092-25Diazepam25 in 1 BOTTLE, PLASTICTABLET2519
55289-092-30Diazepam30 in 1 BOTTLE, PLASTICTABLET3019
55289-092-40Diazepam40 in 1 BOTTLE, PLASTICTABLET4019
55289-092-60Diazepam60 in 1 BOTTLE, PLASTICTABLET6019
55289-092-90Diazepam90 in 1 BOTTLE, PLASTICTABLET9019
55289-092-98Diazepam120 in 1 BOTTLE, PLASTICTABLET12019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-092-01EA - Each55289-09230a1c6fa-6e2c-453d-ad25-28f3f3d23d1512012-07-24
55289-092-02EA - Each55289-0920be5b3d9-0b4b-402b-a4e2-a72b1439a96612012-07-24
55289-092-06EA - Each55289-092626d7961-9e92-493d-9c57-97af66e371aa12012-07-24
55289-092-10EA - Each55289-092e88a572c-2a9e-4b99-9db7-8599f1fc483312012-07-24
55289-092-20EA - Each55289-092bb04de12-8760-4bf2-9de4-c2870b182f3512012-07-24
55289-092-25EA - Each55289-092be0bfa21-ad99-4f3b-8972-0c736e51a4df12012-07-24
55289-092-30EA - Each55289-09246f02670-f7b7-4257-82ca-7060788958a912012-07-24
55289-092-40EA - Each55289-092e7342c8b-d281-4624-aa4d-adb5a210d5b512012-07-24
55289-092-60EA - Each55289-09240c28b48-e5f1-4ea4-95c4-f30260ceb65212012-07-24
55289-092-90EA - Each55289-0921b52ba61-51e5-4ca7-a79e-deb8b986ddfa12012-07-24
55289-092-98EA - Each55289-092f44d8ece-b890-4cb9-8fe4-df2ae9df086b12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-092DIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 11 package rows20240312_c2768add-5e01-4ff4-afa3-230380d59a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNc2768add-5e01-4ff4-afa3-230380d59a1f19
197589diazepam 10 MG Oral TabletSCDc2768add-5e01-4ff4-afa3-230380d59a1f19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-092-0155289009201100 TABLET in 1 BOTTLE, PLASTIC (55289-092-01) 100 tablet2010-01-010000-00-00NoNoCurrent
55289-092-02552890092022 TABLET in 1 BOTTLE, PLASTIC (55289-092-02) 2 tablet2010-01-010000-00-00NoNoCurrent
55289-092-06552890092066 TABLET in 1 BOTTLE, PLASTIC (55289-092-06) 6 tablet2010-01-010000-00-00NoNoCurrent
55289-092-105528900921010 TABLET in 1 BOTTLE, PLASTIC (55289-092-10) 10 tablet2010-01-010000-00-00NoNoCurrent
55289-092-205528900922020 TABLET in 1 BOTTLE, PLASTIC (55289-092-20) 20 tablet2010-01-010000-00-00NoNoCurrent
55289-092-255528900922525 TABLET in 1 BOTTLE, PLASTIC (55289-092-25) 25 tablet2010-01-010000-00-00NoNoCurrent
55289-092-305528900923030 TABLET in 1 BOTTLE, PLASTIC (55289-092-30) 30 tablet2010-01-010000-00-00NoNoCurrent
55289-092-405528900924040 TABLET in 1 BOTTLE, PLASTIC (55289-092-40) 40 tablet2010-01-010000-00-00NoNoCurrent
55289-092-605528900926060 TABLET in 1 BOTTLE, PLASTIC (55289-092-60) 60 tablet2010-01-010000-00-00NoNoCurrent
55289-092-905528900929090 TABLET in 1 BOTTLE, PLASTIC (55289-092-90) 90 tablet2010-01-010000-00-00NoNoCurrent
55289-092-9855289009298120 TABLET in 1 BOTTLE, PLASTIC (55289-092-98) 120 tablet2010-01-010000-00-00NoNoCurrent