Home NDC 63629-7046 Nefazodone Hydrochloride
Product NDC 63629-7046
11-digit product format 636297046
Labeler code 63629
Product ID 63629-7046_8962e4a7-1e27-4a03-ab51-34fc4f9c6847
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nefazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076037
Marketing category ANDA
Marketing start 2003-09-16
Substance NEFAZODONE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 70 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 150 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098666 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7046-1 2025-09-04 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-2 2025-09-04 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-3 2025-09-04 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-4 2025-09-04 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-1 2024-01-30 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-2 2024-01-30 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-3 2024-01-30 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-4 2024-01-30 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-1 2020-02-25 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-2 2020-02-25 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-3 2020-02-25 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-4 2020-02-25 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-1 2020-01-31 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-2 2020-01-31 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-3 2020-01-31 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included) 63629-7046-4 2020-01-31 Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7046-1 Nefazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 19 63629-7046-2 Nefazodone Hydrochloride 120 in 1 BOTTLE TABLET 120 19 63629-7046-3 Nefazodone Hydrochloride 28 in 1 BOTTLE TABLET 28 19 63629-7046-4 Nefazodone Hydrochloride 60 in 1 BOTTLE TABLET 60 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7046 NEFAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 18 Current NDC, Legacy NDC, 4 package rows 20220217_0bd4c34a-4f43-4c84-8b98-1d074cba97d5.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 63629-7046-1 63629704601 30 TABLET in 1 BOTTLE (63629-7046-1) 30 tablet 2022-02-08 0000-00-00 No No Current 63629-7046-2 63629704602 120 TABLET in 1 BOTTLE (63629-7046-2) 120 tablet 2016-10-18 0000-00-00 No No Current 63629-7046-3 63629704603 28 TABLET in 1 BOTTLE (63629-7046-3) 28 tablet 2022-02-08 0000-00-00 No No Current 63629-7046-4 63629704604 60 TABLET in 1 BOTTLE (63629-7046-4) 60 tablet 2022-02-08 0000-00-00 No No Current