Home NDC 12634-193 Trazodone Hydrochloride
Product NDC 12634-193
11-digit product format 126340193
Labeler code 12634
Product ID 12634-193_467cacc2-6470-342c-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotheca Inc.
Application ANDA072192
Marketing category ANDA
Marketing start 2010-05-30
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 50 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072192-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072192-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A072192-001 AB 1 a50c72e98297…
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 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 12634-193-00 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-01 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-09 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-12 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-18 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-40 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-42 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-45 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-50 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-52 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-54 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-57 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-59 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-60 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-61 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-63 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-66 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-67 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-69 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-71 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-74 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-78 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-79 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-80 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-81 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-82 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-84 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-85 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-90 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-91 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-92 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-93 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-94 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-95 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-96 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-97 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-98 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 12634-193-99 2020-01-31 C162847 48780-1 9d75b9d0-c811-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-193-00 Trazodone Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 1 12634-193-01 Trazodone Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 12634-193-09 Trazodone Hydrochloride 35 in 1 BOTTLE TABLET, FILM COATED 35 1 12634-193-12 Trazodone Hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 1 12634-193-18 Trazodone Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 1 12634-193-40 Trazodone Hydrochloride 40 in 1 BOTTLE TABLET, FILM COATED 40 1 12634-193-42 Trazodone Hydrochloride 42 in 1 BOTTLE TABLET, FILM COATED 42 1 12634-193-45 Trazodone Hydrochloride 45 in 1 BOTTLE TABLET, FILM COATED 45 1 12634-193-50 Trazodone Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 1 12634-193-52 Trazodone Hydrochloride 12 in 1 BLISTER PACK TABLET, FILM COATED 12 1 12634-193-54 Trazodone Hydrochloride 14 in 1 BLISTER PACK TABLET, FILM COATED 14 1 12634-193-57 Trazodone Hydrochloride 20 in 1 BLISTER PACK TABLET, FILM COATED 20 1 12634-193-59 Trazodone Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1 12634-193-60 Trazodone Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 12634-193-61 Trazodone Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 12634-193-63 Trazodone Hydrochloride 3 in 1 BLISTER PACK TABLET, FILM COATED 3 1 12634-193-66 Trazodone Hydrochloride 6 in 1 BLISTER PACK TABLET, FILM COATED 6 1 12634-193-67 Trazodone Hydrochloride 7 in 1 BLISTER PACK TABLET, FILM COATED 7 1 12634-193-69 Trazodone Hydrochloride 9 in 1 BLISTER PACK TABLET, FILM COATED 9 1 12634-193-71 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1 12634-193-74 Trazodone Hydrochloride 24 in 1 BOTTLE TABLET, FILM COATED 24 1 12634-193-78 Trazodone Hydrochloride 28 in 1 BOTTLE TABLET, FILM COATED 28 1 12634-193-79 Trazodone Hydrochloride 25 in 1 BOTTLE TABLET, FILM COATED 25 1 12634-193-80 Trazodone Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 1 12634-193-81 Trazodone Hydrochloride 21 in 1 BOTTLE TABLET, FILM COATED 21 1 12634-193-82 Trazodone Hydrochloride 12 in 1 BOTTLE TABLET, FILM COATED 12 1 12634-193-84 Trazodone Hydrochloride 14 in 1 BOTTLE TABLET, FILM COATED 14 1 12634-193-85 Trazodone Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 1 12634-193-90 Trazodone Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 1 12634-193-91 Trazodone Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 1 12634-193-92 Trazodone Hydrochloride 2 in 1 BOTTLE TABLET, FILM COATED 2 1 12634-193-93 Trazodone Hydrochloride 3 in 1 BOTTLE TABLET, FILM COATED 3 1 12634-193-94 Trazodone Hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 1 12634-193-95 Trazodone Hydrochloride 5 in 1 BOTTLE TABLET, FILM COATED 5 1 12634-193-96 Trazodone Hydrochloride 6 in 1 BOTTLE TABLET, FILM COATED 6 1 12634-193-97 Trazodone Hydrochloride 7 in 1 BOTTLE TABLET, FILM COATED 7 1 12634-193-98 Trazodone Hydrochloride 8 in 1 BOTTLE TABLET, FILM COATED 8 1 12634-193-99 Trazodone Hydrochloride 9 in 1 BOTTLE TABLET, FILM COATED 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-193 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.] 1 Legacy NDC, 38 package rows 20170123_467cacc2-646f-342c-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 12634-193-00 12634019300 10 in 1 BOTTLE Historical 12634-193-01 12634019301 100 in 1 BOTTLE Historical 12634-193-09 12634019309 35 in 1 BOTTLE Historical 12634-193-12 12634019312 120 in 1 BOTTLE Historical 12634-193-18 12634019318 180 in 1 BOTTLE Historical 12634-193-40 12634019340 40 in 1 BOTTLE Historical 12634-193-42 12634019342 42 in 1 BOTTLE Historical 12634-193-45 12634019345 45 in 1 BOTTLE Historical 12634-193-50 12634019350 50 in 1 BOTTLE Historical 12634-193-52 12634019352 12 in 1 BLISTER PACK Historical 12634-193-54 12634019354 14 in 1 BLISTER PACK Historical 12634-193-57 12634019357 20 in 1 BLISTER PACK Historical 12634-193-59 12634019359 30 in 1 BLISTER PACK Historical 12634-193-60 12634019360 60 in 1 BOTTLE Historical 12634-193-61 12634019361 10 in 1 BLISTER PACK Historical 12634-193-63 12634019363 3 in 1 BLISTER PACK Historical 12634-193-66 12634019366 6 in 1 BLISTER PACK Historical 12634-193-67 12634019367 7 in 1 BLISTER PACK Historical 12634-193-69 12634019369 9 in 1 BLISTER PACK Historical 12634-193-71 12634019371 30 in 1 BOTTLE Historical 12634-193-74 12634019374 24 in 1 BOTTLE Historical 12634-193-78 12634019378 28 in 1 BOTTLE Historical 12634-193-79 12634019379 25 in 1 BOTTLE Historical 12634-193-80 12634019380 20 in 1 BOTTLE Historical 12634-193-81 12634019381 21 in 1 BOTTLE Historical 12634-193-82 12634019382 12 in 1 BOTTLE Historical 12634-193-84 12634019384 14 in 1 BOTTLE Historical 12634-193-85 12634019385 15 in 1 BOTTLE Historical 12634-193-90 12634019390 90 in 1 BOTTLE Historical 12634-193-91 12634019391 1 in 1 BLISTER PACK Historical 12634-193-92 12634019392 2 in 1 BOTTLE Historical 12634-193-93 12634019393 3 in 1 BOTTLE Historical 12634-193-94 12634019394 4 in 1 BOTTLE Historical 12634-193-95 12634019395 5 in 1 BOTTLE Historical 12634-193-96 12634019396 6 in 1 BOTTLE Historical 12634-193-97 12634019397 7 in 1 BOTTLE Historical 12634-193-98 12634019398 8 in 1 BOTTLE Historical 12634-193-99 12634019399 9 in 1 BOTTLE Historical