FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197591

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

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