Nefazodone Hydrochloride

Product NDC: 21695-176
11-digit product format: 216950176
Labeler code: 21695
Product ID: 21695-176_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: 200 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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-176		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-176	21695-176-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-176	21695-176-60	I	Inactivated by FDA	2026-08-03

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

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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`5bbf6a4d5a75…`

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 · 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

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
21695-176-30	2019-09-24	C162847	48780-1	934fe258-4ab2-48b1-e053-8cdaa90a720a	NEFAZODONE HYDROCHLORIDE TABLETS 7178 1024 7113 1025 1026 (Patient Information Included)
21695-176-60	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
21695-176-30	Nefazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30		1
21695-176-60	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
21695-176-30	EA - Each	21695-176	c2e906d0-cbea-4294-b479-42b553cae64a	1	2012-07-24
21695-176-60	EA - Each	21695-176	33dcd89c-9fd1-428c-b22b-f986ef8d9a51	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
21695-176	NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110622_4afee435-ae60-4260-a1df-e52abf7a043d.zip

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
21695-176-30	21695017630	30 in 1 BOTTLE	Historical
21695-176-60	21695017660	60 in 1 BOTTLE	Historical