bupropion

Product NDC
65841-836
11-digit product format
658410836
Labeler code
65841
Product ID
65841-836_6c831525-a7c2-4ef1-b1b9-c7e8cb807ded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA201567
Marketing category
ANDA
Marketing start
2018-08-02
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201567-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17
A201567-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201567-001AB3
A201567-002AB3

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201567-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201567-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201567-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201567-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201567-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A201567-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201567-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201567-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201567-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201567-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201567-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201567-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201567-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201567-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201567-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201567-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201567-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A201567-002AB31782e0a99824c…

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 · 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
78d34aad-9d4f-48c4-91eb-536e31c6b6c9Available 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
65841-836-05bupropion500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
65841-836-06bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
65841-836-10bupropion1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011
65841-836-16bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SHELLACINACTIVE INGREDIENT46N107B71OBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-836BUPROPION TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 4 package rows20241128_78d34aad-9d4f-48c4-91eb-536e31c6b6c9.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropionBUPROPIONZydus Lifesciences Limited78d34aad-9d4f-48c4-91eb-536e31c6b6c92024-11-26Exact identifier
application applno (ANDA): 201567
application number: ANDA201567
ndc (product): 65841-836
bupropionBUPROPIONZydus Pharmaceuticals USA Inc.8d937ca3-3351-40f1-8192-348ba0c681622024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201567
application number: ANDA201567
bupropionBUPROPIONProficient Rx LP47ceb7e1-b2f7-47f8-8b6a-85eea36606b82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201567
application number: ANDA201567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN78d34aad-9d4f-48c4-91eb-536e31c6b6c911
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD78d34aad-9d4f-48c4-91eb-536e31c6b6c911
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY78d34aad-9d4f-48c4-91eb-536e31c6b6c911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-836-0565841083605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-05) 2018-08-020000-00-00NoNoCurrent
65841-836-066584108360630 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-06) 2018-08-020000-00-00NoNoCurrent
65841-836-10658410836101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-10) 2018-08-020000-00-00NoNoCurrent
65841-836-166584108361690 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-16) 2018-08-020000-00-00NoNoCurrent