Trazodone Hydrochloride

Product NDC
0603-6161
11-digit product format
006036161
Labeler code
0603
Product ID
0603-6161_33d705b2-795f-4fb8-96f2-96d48e6de326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA072193
Marketing category
ANDA
Marketing start
2010-05-30
Marketing end
2021-06-30
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-6161-02EA - Each0603-6161c8075bd6-6723-4653-b379-404bd49b23d512012-07-24
0603-6161-04EA - Each0603-6161b1c6e780-183a-4886-9ebb-bdc4172ab99012012-07-24
0603-6161-16EA - Each0603-61613f659fd0-b1cb-442d-ad34-84f13141a14812012-07-24
0603-6161-20EA - Each0603-6161394ea989-49a2-4e5e-8fb3-2a95c6340bb212012-07-24
0603-6161-21EA - Each0603-6161100dd3d2-9843-40f5-bdfd-0dbcbfe703d612012-07-24
0603-6161-28EA - Each0603-6161c8dca3e9-af0e-4042-8609-e078215586fd12012-07-24
0603-6161-32EA - Each0603-616131ef2a2c-7a09-4de0-b52a-ee4253b2d27312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Trazodone HydrochlorideACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
trazodoneACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
polydextroseINACTIVE INGREDIENTVH2XOU12IETRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
povidoneINACTIVE INGREDIENTFZ989GH94ETRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856373traZODone HCl 100 MG Oral TabletPSN4e0ce52d-2639-42a2-a4e4-7854421fa1b61
856377traZODone HCl 50 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856377traZODone HCl 50 MG Oral TabletPSN4e0ce52d-2639-42a2-a4e4-7854421fa1b61
856373trazodone hydrochloride 100 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181
856373trazodone hydrochloride 100 MG Oral TabletSCD4e0ce52d-2639-42a2-a4e4-7854421fa1b61
856377trazodone hydrochloride 50 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181
856377trazodone hydrochloride 50 MG Oral TabletSCD4e0ce52d-2639-42a2-a4e4-7854421fa1b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0603-6161-2100603616121100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6161-21) 2010-05-302021-06-30NoNoCurrent
0603-6161-2800603616128500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6161-28) 2010-05-302021-05-31NoNoCurrent