FDA.reportPublic FDA data

DIAZEPAM

Product NDC
52959-047
11-digit product format
529590047
Labeler code
52959
Product ID
52959-047_75c7d502-0179-5ba1-e053-2a91aa0a7d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA071135
Marketing category
ANDA
Marketing start
2016-01-25
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-047-002020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-012020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-022020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-032020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-042020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-052020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-062020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-102020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-122020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-142020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-152020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-202020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-212020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-232020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-242020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-252020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-302020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-402020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-452020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-502020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-602020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-047-902020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-047-30Gabavale-530 in 1 BOTTLETABLET305 mg4
52959-047-00DIAZEPAM100 in 1 BOTTLETABLET1001
52959-047-01DIAZEPAM1 in 1 BOTTLETABLET11
52959-047-02DIAZEPAM120 in 1 BOTTLETABLET1201
52959-047-03DIAZEPAM3 in 1 BOTTLETABLET31
52959-047-04DIAZEPAM4 in 1 BOTTLETABLET41
52959-047-05DIAZEPAM5 in 1 BOTTLETABLET51
52959-047-06DIAZEPAM6 in 1 BOTTLETABLET61
52959-047-10DIAZEPAM10 in 1 BOTTLETABLET101
52959-047-12DIAZEPAM12 in 1 BOTTLETABLET121
52959-047-14DIAZEPAM14 in 1 BOTTLETABLET141
52959-047-15DIAZEPAM15 in 1 BOTTLETABLET151
52959-047-20DIAZEPAM20 in 1 BOTTLETABLET201
52959-047-21DIAZEPAM21 in 1 BOTTLETABLET211
52959-047-23DIAZEPAM2 in 1 BOTTLETABLET21
52959-047-24DIAZEPAM24 in 1 BOTTLETABLET241
52959-047-25DIAZEPAM25 in 1 BOTTLETABLET251
52959-047-30DIAZEPAM30 in 1 BOTTLETABLET301
52959-047-40DIAZEPAM40 in 1 BOTTLETABLET401
52959-047-45DIAZEPAM45 in 1 BOTTLETABLET451
52959-047-50DIAZEPAM50 in 1 BOTTLETABLET501
52959-047-60DIAZEPAM60 in 1 BOTTLETABLET601
52959-047-90DIAZEPAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-047-01EA - Each52959-047ca7d049d-94c5-4426-8258-1354174cb4ff12018-10-11
52959-047-02EA - Each52959-04789b2b5ec-3ee8-457a-8ede-74ab3efa357612018-10-11
52959-047-03EA - Each52959-047ea2aa9c9-4127-4dce-a060-959a9579077212018-10-11
52959-047-05EA - Each52959-04729d30819-684d-472b-b336-5950d3bcb88812018-10-11
52959-047-06EA - Each52959-047d3b80100-ea9a-4a42-bae9-88ac95ed48d412018-10-11
52959-047-10EA - Each52959-04751375bb6-53de-4679-af3d-57eb7615d58312018-10-11
52959-047-12EA - Each52959-0476e0ddf81-9629-4fd1-bab7-c828ba4b920f12018-10-11
52959-047-15EA - Each52959-047f28cc7dd-939a-4549-bc8a-f7843fb3cb5c12018-10-11
52959-047-20EA - Each52959-04755a7db19-5de6-439c-864d-f775189c63bf12018-10-11
52959-047-21EA - Each52959-0476eeb201d-fbcd-4078-b404-a3a1829ec5fe12018-10-11
52959-047-25EA - Each52959-047cc174afe-2598-4d31-89ac-3a601e47407a12018-10-11
52959-047-30EA - Each52959-047a28957aa-37b9-42f0-826a-8a675115118a12018-10-11
52959-047-40EA - Each52959-047a5a2644c-6eea-4f2e-825a-c359c7ab2bda12018-10-11
52959-047-45EA - Each52959-047a7b99a96-22a7-4be3-8f59-2f01cf9f9cc112018-10-11
52959-047-50EA - Each52959-047cbd39c0c-ffb9-41fe-950a-c75e80fbe91812018-10-11
52959-047-60EA - Each52959-047e195f88a-56a7-485d-a4dc-9588abcfe10512018-10-11
52959-047-90EA - Each52959-047be27e56d-8900-4be0-a1f1-3b63c30f0b8612018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
CHOLINEACTIVE MOIETYN91BDP6H0XGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
GELATININACTIVE INGREDIENT2G86QN327LGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-047GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]4Legacy NDC20110812_188b8a95-3db7-4a6a-bddf-48b83a0c8e38.zip
52959-047DIAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 22 package rows20180926_75c7d502-0178-5ba1-e053-2a91aa0a7d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN188b8a95-3db7-4a6a-bddf-48b83a0c8e384
197591diazepam 5 MG Oral TabletSCD188b8a95-3db7-4a6a-bddf-48b83a0c8e384
197589diazePAM 10 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197590diazePAM 2 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197591diazePAM 5 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197589diazepam 10 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671
197590diazepam 2 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671
197591diazepam 5 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-047-0052959004700100 in 1 BOTTLEHistorical
52959-047-01529590047011 in 1 BOTTLEHistorical
52959-047-0252959004702120 in 1 BOTTLEHistorical
52959-047-03529590047033 in 1 BOTTLEHistorical
52959-047-04529590047044 in 1 BOTTLEHistorical
52959-047-05529590047055 in 1 BOTTLEHistorical
52959-047-06529590047066 in 1 BOTTLEHistorical
52959-047-105295900471010 in 1 BOTTLEHistorical
52959-047-125295900471212 in 1 BOTTLEHistorical
52959-047-145295900471414 in 1 BOTTLEHistorical
52959-047-155295900471515 in 1 BOTTLEHistorical
52959-047-205295900472020 in 1 BOTTLEHistorical
52959-047-215295900472121 in 1 BOTTLEHistorical
52959-047-23529590047232 in 1 BOTTLEHistorical
52959-047-245295900472424 in 1 BOTTLEHistorical
52959-047-255295900472525 in 1 BOTTLEHistorical
52959-047-305295900473030 in 1 BOTTLEHistorical
52959-047-405295900474040 in 1 BOTTLEHistorical
52959-047-455295900474545 in 1 BOTTLEHistorical
52959-047-505295900475050 in 1 BOTTLEHistorical
52959-047-605295900476060 in 1 BOTTLEHistorical
52959-047-905295900479090 in 1 BOTTLEHistorical