Home NDC 0093-1025 Nefazodone Hydrochloride
Product NDC 0093-1025
11-digit product format 000931025
Labeler code 0093
Product ID 0093-1025_11cdc932-271c-4988-aad9-076340888bce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nefazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076037
Marketing category ANDA
Marketing start 2003-09-16
Substance NEFAZODONE HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076037-001 NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 A076037-002 NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 A076037-003 NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 A076037-004 NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 A076037-005 NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16
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.
Product history page 1 of 6 · 210 observed 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 2026-08-18 06:07:40 2026-07 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076037-001 NEFAZODONE HYDROCHLORIDE 50MG TABLET / ORAL 2003-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076037-002 NEFAZODONE HYDROCHLORIDE 100MG TABLET / ORAL 2003-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076037-003 NEFAZODONE HYDROCHLORIDE 150MG TABLET / ORAL 2003-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076037-004 NEFAZODONE HYDROCHLORIDE 200MG TABLET / ORAL 2003-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076037-005 NEFAZODONE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-09-16 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Nefazodone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEFAZODONE HYDROCHLORIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 27X63J94GR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098649 Internal RxNorm lookup 1098666 Internal RxNorm lookup 1098670 Internal RxNorm lookup 1098674 Internal RxNorm lookup 1098678 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-1025-06 Nefazodone Hydrochloride 60 in 1 BOTTLE TABLET 60 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-1025 NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20220716_51ff7db5-aaf9-4c3c-86e6-958ebf16b60f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-1025-06 00093102506 60 TABLET in 1 BOTTLE (0093-1025-06) 60 tablet 2003-09-16 0000-00-00 No No Current