Nefazodone Hydrochloride

Product NDC: 21695-175
11-digit product format: 216950175
Labeler code: 21695
Product ID: 21695-175_4afee435-ae60-4260-a1df-e52abf7a043d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nefazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076037
Marketing category: ANDA
Marketing start: 2003-09-16
Marketing end: 0000-00-00
Substance: NEFAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-175		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-175	21695-175-60	I	Inactivated by FDA		2026-08-17

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 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-175-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-175-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-175-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-175-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-175-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-175-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-175-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-175-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-175-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-175-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-175-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-175-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-175-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-175-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-175-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-175-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-175-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-175-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-175-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-175-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-175-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-175-60	`110d247fa046…`	`a55b01930146…`

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	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	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
88e577a5-ea68-76d2-a3c4-7157b94bcfa5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-175-60	2019-09-24	C162847	48780-1	934fe258-4ab2-48b1-e053-8cdaa90a720a	NEFAZODONE HYDROCHLORIDE TABLETS 7178 1024 7113 1025 1026 (Patient Information Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-175-60	Nefazodone Hydrochloride	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-175-60	EA - Each	21695-175	d8724dc7-97c2-44e6-9321-19f278d5a0ba	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nefazodone hydrochloride	ACTIVE INGREDIENT	27X63J94GR	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
nefazodone	ACTIVE MOIETY	59H4FCV1TF	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-175	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110622_4afee435-ae60-4260-a1df-e52abf7a043d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	0bd4c34a-4f43-4c84-8b98-1d074cba97d5	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076037 application number: ANDA076037
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	51ff7db5-aaf9-4c3c-86e6-958ebf16b60f	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076037 application number: ANDA076037

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27X63J94GR	NEFAZODONE HYDROCHLORIDE	82752-99-6	NEFAZODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098649	nefazodone HCl 100 MG Oral Tablet	PSN	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098666	nefazodone HCl 150 MG Oral Tablet	PSN	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098670	nefazodone HCl 200 MG Oral Tablet	PSN	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098674	nefazodone HCl 250 MG Oral Tablet	PSN	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098649	nefazodone hydrochloride 100 MG Oral Tablet	SCD	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098666	nefazodone hydrochloride 150 MG Oral Tablet	SCD	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098670	nefazodone hydrochloride 200 MG Oral Tablet	SCD	4afee435-ae60-4260-a1df-e52abf7a043d	1
1098674	nefazodone hydrochloride 250 MG Oral Tablet	SCD	4afee435-ae60-4260-a1df-e52abf7a043d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-175-60	21695017560	60 in 1 BOTTLE	Historical