bupropion hydrochloride

Product NDC
16571-863
11-digit product format
165710863
Labeler code
16571
Product ID
16571-863_fe42636a-ae04-43be-b032-8973bbdde7d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211020
Marketing category
ANDA
Marketing start
2022-08-01
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 42.

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
A211020-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28
A211020-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211020-001AB3
A211020-002AB3

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211020-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A211020-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211020-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211020-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211020-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211020-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211020-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211020-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211020-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211020-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211020-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211020-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211020-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211020-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211020-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211020-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211020-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211020-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211020-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211020-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211020-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A211020-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211020-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211020-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211020-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211020-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211020-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211020-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211020-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211020-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211020-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211020-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211020-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211020-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211020-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211020-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211020-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211020-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211020-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211020-002AB31bb7c543d1eb4…

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
e4f4d3fa-ddf6-4125-8486-8157efc095c1Available 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
16571-863-03bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE304
16571-863-09bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE904
16571-863-10bupropion hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
16571-863-50bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-863-03EA - Each16571-8639b7e3e60-40a8-4696-9399-4da747650eb212022-08-04
16571-863-09EA - Each16571-8634ee1206f-f288-406d-9103-c010e0ccf0be12022-08-04
16571-863-50EA - Each16571-86321472737-a79a-418b-8a7e-d5aeb3fcb47f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-863BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 4 package rows20241114_e4f4d3fa-ddf6-4125-8486-8157efc095c1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacka613cfd3-1aa1-49c5-b742-b105c97d73f12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.136f29fa-a859-4efb-8365-1382716d6f8f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
bupropion hydrochlorideBUPROPION HYDROCHLORIDERising Pharma Holdings, Inc.e4f4d3fa-ddf6-4125-8486-8157efc095c12026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
ndc (product): 16571-863
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.d087222e-c5e9-4c48-b27f-e2e2944379c82025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsaeb506f8-97c2-409a-aac9-5a73c840e8f32024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNe4f4d3fa-ddf6-4125-8486-8157efc095c14
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNe4f4d3fa-ddf6-4125-8486-8157efc095c14
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDe4f4d3fa-ddf6-4125-8486-8157efc095c14
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDe4f4d3fa-ddf6-4125-8486-8157efc095c14
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYe4f4d3fa-ddf6-4125-8486-8157efc095c14
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYe4f4d3fa-ddf6-4125-8486-8157efc095c14
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNd087222e-c5e9-4c48-b27f-e2e2944379c82
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDd087222e-c5e9-4c48-b27f-e2e2944379c82
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYd087222e-c5e9-4c48-b27f-e2e2944379c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-863-031657108630330 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-03) 2022-08-010000-00-00NoNoCurrent
16571-863-091657108630990 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-09) 2022-08-010000-00-00NoNoCurrent
16571-863-10165710863101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-10) 2022-08-010000-00-00NoNoCurrent
16571-863-5016571086350500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-50) 2022-08-010000-00-00NoNoCurrent