Bupropion Hydrochloride Extended Release

Product NDC
10135-703
Requested package NDC
10135-703-30
11-digit product format
101350703
Labeler code
10135
Product ID
10135-703_c9b12a1f-3e31-0811-e053-2995a90a4d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA211200
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10135-70310135-703-30IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A211200-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05
A211200-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211200-001AB3
A211200-002AB3

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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211200-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32020-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211200-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-09-05bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211200-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A211200-002AB3184e616aacf4f…
2026-08-18 06:07:402026-07A211200-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A211200-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211200-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211200-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211200-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211200-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211200-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211200-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211200-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211200-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211200-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211200-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211200-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211200-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211200-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211200-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211200-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211200-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211200-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211200-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211200-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A211200-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211200-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211200-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211200-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211200-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211200-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211200-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211200-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211200-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211200-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211200-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211200-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211200-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211200-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211200-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211200-001AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211200-001AB31bb7c543d1eb4…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-703-05Bupropion Hydrochloride Extended Release500 in 1 BOTTLETABLET5005
10135-703-30Bupropion Hydrochloride Extended Release30 in 1 BOTTLETABLET305
10135-703-90Bupropion Hydrochloride Extended Release90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-703-05EA - Each10135-703ed65c47c-d103-42ca-b9de-32c0637bc7b412021-04-08
10135-703-30EA - Each10135-70333b221f7-9e87-4613-804c-3f28787efe7e12021-04-08
10135-703-90EA - Each10135-7038929d58d-cd9d-4748-a023-4c21f4f3f70012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-703BUPROPION HYDROCHLORIDE EXTENDED RELEASE (BUPROPION HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC]5Legacy NDC, 3 package rows20210819_cf69c6c4-d2d8-4a41-aff8-a67abd3a037e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
buPropion Hydrochloride XLBUPROPION HYDROCHLORIDEOryza pharmaceuticals Inc.004d8121-59d4-46c4-acb8-b2dd097bf5562025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211200
application number: ANDA211200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNcbc83743-3738-401b-bb2d-ad668438607c1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDcbc83743-3738-401b-bb2d-ad668438607c1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYcbc83743-3738-401b-bb2d-ad668438607c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-703-301013507033030 TABLET in 1 BOTTLE (10135-703-30) 30 tablet2020-07-010000-00-00NoNoCurrent