Bupropion Hydrochloride

Product NDC
63187-952
11-digit product format
631870952
Labeler code
63187
Product ID
63187-952_3bfee467-f720-4aa7-aeff-6b07c1618808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-03-24
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
A079095-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24
A079095-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24
A079095-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079095-001AB1
A079095-002AB1
A079095-003AB1

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12009-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12009-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079095-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12009-03-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079095-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079095-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079095-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079095-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079095-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079095-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079095-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079095-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079095-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079095-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079095-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079095-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079095-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079095-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A079095-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A079095-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079095-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079095-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079095-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079095-001AB118072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 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
993503Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b59d950c-341f-45f1-b5b2-d64ccc799580Available 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
63187-952-14Bupropion HydrochlorideSR14 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE145
63187-952-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE305
63187-952-60Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE605
63187-952-90Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-952-14EA - Each63187-95221073042-58ac-47b3-8b33-5e690dcc5ecc12024-06-10
63187-952-30EA - Each63187-95271dfc3aa-7906-4d54-8c97-05312db11ded12023-04-07
63187-952-60EA - Each63187-952fa7ce361-cff7-4502-b269-8d82cc586a6c12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-952BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20240511_b59d950c-341f-45f1-b5b2-d64ccc799580.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuPROPion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging1af890f7-1db8-4dd2-bf66-2b1e0c93a3d82026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f58ce435-b124-4519-98d8-de2d00f61b012026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEActavis Pharma, Inc.cec41945-8d64-4793-8784-4c2b8ec37b0f2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepackec8c699f-a8de-4e5a-a223-8de3f5dfe20d2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LPb59d950c-341f-45f1-b5b2-d64ccc7995802024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
ndc (product): 63187-952
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LP13770e60-117c-4814-93bb-9bc41a042a202022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LPa165869a-9bc4-4987-babe-a77fad78c38f2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079095
application number: ANDA079095

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNb59d950c-341f-45f1-b5b2-d64ccc7995805
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDb59d950c-341f-45f1-b5b2-d64ccc7995805
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYb59d950c-341f-45f1-b5b2-d64ccc7995805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-952-146318709521414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-14) 2024-05-07NoNoCurrent
63187-952-306318709523030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-30) 2018-01-010000-00-00NoNoCurrent
63187-952-606318709526060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-60) 2018-01-010000-00-00NoNoCurrent
63187-952-906318709529090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-90) 2018-01-010000-00-00NoNoCurrent