FDA.reportPublic FDA data

Diazepam

Product NDC
0409-3213
11-digit product format
004093213
Labeler code
0409
Product ID
0409-3213_54805cd5-8b81-402d-bb07-ffb5293222b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA071583
Marketing category
ANDA
Marketing start
2007-10-05
Substance
DIAZEPAM
Active strength
5 mg/mL
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
DIAZEPAM5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui309845

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3213-11Diazepam10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1026
0409-3213-12Diazepam10 in 1 BOXINJECTION, SOLUTION1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3213-02ML - Milliliter0409-32131d84cf13-0cde-4a69-84d1-480c421d7bd012012-07-24
0409-3213-09ML - Milliliter0409-3213e187dd62-7641-41ee-b50e-620e72ade01612016-03-04
0409-3213-10ML - Milliliter0409-321327d841aa-f6d0-4999-a0f6-ea3d97843f7b12016-03-04
0409-3213-11ML - Milliliter0409-3213b22ea37c-eb85-47a9-b813-c54bca32439412020-01-03
0409-3213-12ML - Milliliter0409-3213fd572111-27af-4edc-8ee5-19e928e4b71212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]12
DiazepamACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
DiazepamACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MDIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHDIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3213DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]25Current NDC, Legacy NDC, 2 package rows20241220_7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309845diazePAM 5 MG/ML Injectable SolutionPSN7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f26
309845diazepam 5 MG/ML Injectable SolutionSCD7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f26
309845diazePAM 5 MG/ML Injectable SolutionPSNbfa85a63-967f-4176-a752-0bafabbaaae37
309845diazepam 5 MG/ML Injectable SolutionSCDbfa85a63-967f-4176-a752-0bafabbaaae37
309845diazePAM 5 MG/ML Injectable SolutionPSNc8e979a8-af6b-f0c4-e053-2995a90ae63f2
309845diazepam 5 MG/ML Injectable SolutionSCDc8e979a8-af6b-f0c4-e053-2995a90ae63f2
309845diazePAM 5 MG/ML Injectable SolutionPSN23d3765c-8f10-4bfc-9489-e1ed064ad8131
309845diazePAM 5 MG/ML Injectable SolutionPSNd1b5762f-307c-4c99-977d-d91d7dd221411
309845diazepam 5 MG/ML Injectable SolutionSCD23d3765c-8f10-4bfc-9489-e1ed064ad8131
309845diazepam 5 MG/ML Injectable SolutionSCDd1b5762f-307c-4c99-977d-d91d7dd221411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3213-110040932131110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0409-3213-120040932131210 VIAL, MULTI-DOSE in 1 BOX (0409-3213-12) / 10 mL in 1 VIAL, MULTI-DOSE (0409-3213-11) 2007-10-050000-00-00NoNoCurrent