FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
31722-488
11-digit product format
317220488
Labeler code
31722
Product ID
31722-488_500b524c-53eb-26fe-e063-6394a90a8da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217898
Marketing category
ANDA
Marketing start
2025-10-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217898-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01
A217898-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217898-001AB3
A217898-002AB3

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
2026-02-19 14:30 UTC2026-02A217898-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217898-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217898-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32025-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217898-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32025-10-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217898-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217898-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32025-10-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217898-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217898-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217898-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217898-002AB3131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217898-001AB31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217898-002AB31a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993541Internal RxNorm lookup
993557Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c71f18b7-36a3-4489-96b4-e8fbec4f73a1Available 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
31722-488-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
31722-488-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
31722-488-90BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.c71f18b7-36a3-4489-96b4-e8fbec4f73a12026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217898
application number: ANDA217898
ndc (product): 31722-488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNc71f18b7-36a3-4489-96b4-e8fbec4f73a12
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc71f18b7-36a3-4489-96b4-e8fbec4f73a12
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYc71f18b7-36a3-4489-96b4-e8fbec4f73a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-488-0531722048805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-488-05) 2025-10-01NoNoCurrent
31722-488-303172204883030 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-488-30) 2025-10-01NoNoCurrent
31722-488-903172204889090 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-488-90) 2025-10-01NoNoCurrent