Bupropion Hydrochloride

Product NDC: 63629-8475
11-digit product format: 636298475
Labeler code: 63629
Product ID: 63629-8475_fb604f37-45d9-4fe0-bce9-24bb6a045a14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207479
Marketing category: ANDA
Marketing start: 2017-04-12
Substance: BUPROPION HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207479-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12
A207479-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207479-001	AB3
A207479-002	AB3

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	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12	`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	A207479-001	AB3	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207479-002	AB3	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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	8499470a-8d01-4348-b67b-8f49728031cb	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	cefaaa17-f79a-4ba6-8f97-a59f60e07b75	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	03b1b0a9-0aa2-4039-acce-68ca54abaae4	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a5417808-f767-48fc-9f5d-c1aeee4e57c3	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 63629-8475
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a7553281-be90-47e3-8d2b-b027f6d18d3a	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	16a788ff-8bd5-4f70-a3fd-a89db019e435	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals,Inc.	05f82eca-cc87-4580-acd7-e6491c651881	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	4ddf6ba2-c020-7912-e063-6394a90a7964	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	459bd1c9-d7a5-8bc9-e063-6394a90a8ecd	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	722650d8-5ee4-48ba-9827-7c86b1283522	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	16ffe2ac-4f71-4843-99df-611f53c2f3cd	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d826804-6427-aae1-e063-6394a90a6593	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	57a9f4d3-0c41-4978-b81e-cf3059bc8c42	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	0ac739de-ad59-4882-810e-f52db22ac96f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d6efb695-c439-48d7-a155-5c661a5049af	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cipla USA., Inc.	0abd64f7-5142-48f6-a487-3f5bdc3400de	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: (XL)
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZG7E5POY8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993557	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a5417808-f767-48fc-9f5d-c1aeee4e57c3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8475-1	Bupropion Hydrochloride(XL)	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	500		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8475-1	EA - Each	63629-8475	3cc78a82-fde3-4dd2-a710-8e3467151a3b	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8475	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20240112_a5417808-f767-48fc-9f5d-c1aeee4e57c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8475-1	63629847501	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8475-1)	2017-04-12	0000-00-00	No	No	Current