FDA.reportPublic FDA data

Diazepam

Product NDC
63187-544
11-digit product format
631870544
Labeler code
63187
Product ID
63187-544_aeef8cde-a187-453e-b7fb-e179493ff427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071322
Marketing category
ANDA
Marketing start
1986-12-10
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
63187-544-06Diazepam6 in 1 BOTTLETABLET64
63187-544-15Diazepam15 in 1 BOTTLETABLET154
63187-544-20Diazepam20 in 1 BOTTLETABLET204
63187-544-30Diazepam30 in 1 BOTTLETABLET304
63187-544-60Diazepam60 in 1 BOTTLETABLET604
63187-544-90Diazepam90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-544-06EA - Each63187-5445d3748e0-695a-4f48-ade9-ad849bc7726e12020-03-10
63187-544-20EA - Each63187-54492de2342-f5ed-4a95-b2e7-c4554c63cb6312023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PROFICIENT RX LP]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PROFICIENT RX LP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIAZEPAM TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-544DIAZEPAM TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220816_f8d26f65-a015-4bfc-b1fa-8595d72af48c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNf8d26f65-a015-4bfc-b1fa-8595d72af48c4
197589diazepam 10 MG Oral TabletSCDf8d26f65-a015-4bfc-b1fa-8595d72af48c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-544-06631870544066 TABLET in 1 BOTTLE (63187-544-06) 6 tablet2019-12-170000-00-00NoNoCurrent
63187-544-156318705441515 TABLET in 1 BOTTLE (63187-544-15) 15 tablet2018-12-010000-00-00NoNoCurrent
63187-544-206318705442020 TABLET in 1 BOTTLE (63187-544-20) 20 tablet2018-12-010000-00-00NoNoCurrent
63187-544-306318705443030 TABLET in 1 BOTTLE (63187-544-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-544-606318705446060 TABLET in 1 BOTTLE (63187-544-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-544-906318705449090 TABLET in 1 BOTTLE (63187-544-90) 90 tablet2018-12-010000-00-00NoNoCurrent