FDA.reportPublic FDA data

bupropion

Product NDC
71205-565
11-digit product format
712050565
Labeler code
71205
Product ID
71205-565_64c33202-1fb1-4e0a-ae72-146375fa81aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202304-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202304-001AB1
A202304-002AB1
A202304-003AB1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202304-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-003AB11a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.850ac56a-ba50-4e61-b1ee-805e17735b5c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDENorthwind Health Company, LLCab6cd2ea-507c-35e5-e053-2a95a90ac5cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEProficient Rx LP909204fc-ff55-43d9-b9ee-e607ef60965e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
ndc (product): 71205-565

Additional Listing Data#

Finished product
Yes
Brand name base
bupropion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993518Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
909204fc-ff55-43d9-b9ee-e607ef60965eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-565-30bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-565-60bupropion60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-565-90bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-565-30EA - Each71205-5654eb397ba-a518-42d3-801c-ccc7ec78203612021-10-08
71205-565-60EA - Each71205-565bd461bda-ffd8-466e-b44e-0617d31435a512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-565BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220413_909204fc-ff55-43d9-b9ee-e607ef60965e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN909204fc-ff55-43d9-b9ee-e607ef60965e2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD909204fc-ff55-43d9-b9ee-e607ef60965e2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY909204fc-ff55-43d9-b9ee-e607ef60965e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-565-307120505653030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-30) 2021-05-110000-00-00NoNoCurrent
71205-565-607120505656060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-60) 2021-05-110000-00-00NoNoCurrent
71205-565-907120505659090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-90) 2021-05-110000-00-00NoNoCurrent