Bupropion hydrochloride

Product NDC
71335-2499
Requested package NDC
71335-2499-6
11-digit product format
713352499
Labeler code
71335
Product ID
71335-2499_1a76f460-218f-4e30-a86c-7b47120b5ecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215568
Marketing category
ANDA
Marketing start
2022-12-15
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 43.

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
A215568-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02
A215568-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215568-001AB3
A215568-002AB3

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.

Product history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0284e616aacf4f…
2026-08-18 06:07:402026-07A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215568-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215568-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32022-02-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215568-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A215568-002AB3184e616aacf4f…
2026-08-18 06:07:402026-07A215568-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A215568-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215568-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215568-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215568-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215568-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215568-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215568-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215568-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215568-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215568-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215568-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215568-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215568-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215568-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215568-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215568-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215568-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215568-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215568-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215568-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A215568-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215568-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215568-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215568-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215568-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215568-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215568-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215568-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215568-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215568-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215568-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215568-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215568-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215568-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215568-002AB314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215568-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215568-002AB31bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bf5e933c-8a84-4dd7-a05d-6c4a82b6c965Available 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
71335-2499-1Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71335-2499-2Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71335-2499-3Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902
71335-2499-4Bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1202
71335-2499-5Bupropion hydrochloride8 in 1 BOTTLETABLET, EXTENDED RELEASE82
71335-2499-6Bupropion hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2499-1EA - Each71335-249962fad88b-3fd1-45e9-be2b-5a1a98ec022612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2499BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2Current NDC, 6 package rows20250122_bf5e933c-8a84-4dd7-a05d-6c4a82b6c965.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEGranules Pharmaceuticals Inc.d9eb0939-63c1-48c4-a444-a899d7924d062026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0b041720-a25d-403e-a72c-601a8bdd80512026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.c60855ca-4fa0-4004-ad19-4abb61100c432026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
ndc (package): 71335-2499-6
ndc (product): 71335-2499
ndc11 (package): 71335249906
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackaf5b1cc8-f078-4a7b-b64a-4cb2de1e57212026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEUnit Dose Solutions, Inc.53c192ca-ac51-cb87-e063-6394a90a6c082026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPf1703bfd-be36-4fde-8e67-df0fb5d933692026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBluePoint Laboratories4956af38-182a-4015-a945-67e40bd387722026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC487271f1-c956-086a-e063-6394a90a2dc72026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.069e6828-e599-4614-9645-9cf1382ac93e2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC2ccbf988-64b6-3a60-e063-6394a90ababa2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.1724f474-d6ab-46af-940f-7f874d4ff7fc2025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215568
application number: ANDA215568

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2499-671335249906180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-6) 2024-09-23NoNoCurrent