FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50268-771
11-digit product format
502680771
Labeler code
50268
Product ID
50268-771_6e1484b2-5a33-7240-e053-2a91aa0a2a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA071196
Marketing category
ANDA
Marketing start
2016-08-08
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-771DDiscontinued by firm2026-07-31
excluded packagepackage50268-77150268-771-15DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071196-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25
A071196-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26
A071196-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071196-001AB
A071196-002AB
A071196-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25a50c72e98297…
2026-08-01 22:54:322026-06A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26a50c72e98297…
2026-08-01 22:54:322026-06A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071196-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.dc1f347e-1acb-4c06-b36e-f15fecb7ac932026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEApotex Corp71961ab1-951d-1493-f76c-2ff25cca2a852026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5d22a06c-9cb8-4b49-8d67-769d181ad70c2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9c4da6ad-d4d1-4e8c-918d-8ac48512a93f2020-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-771-11EA - Each50268-771e2bba309-c18c-45d8-9e1f-7bdc5262467e12016-09-02
50268-771-15EA - Each50268-771b78fb569-6cb0-4e10-815b-19a4b328974012016-09-02