bupropion hydrochloride

Product NDC
16571-862
11-digit product format
165710862
Labeler code
16571
Product ID
16571-862_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
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
2027-12-31
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
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 · 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 UTC2026-02A211020-001BUPROPION 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…
2021-12-28 21:50 UTC2021-12A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28782e0a99824c…

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 UTC2026-02A211020-001AB31011fe1cb6892…
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…
2021-12-28 21:50 UTC2021-12A211020-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A211020-002AB31782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 16571-862
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

Additional Listing Data#

Finished product
Yes
Brand name base
bupropion hydrochloride
Listing expiration
2027-12-31

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
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
16571-862-03bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE304
16571-862-09bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE904
16571-862-10bupropion hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
16571-862-12bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1204
16571-862-50bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-862-03EA - Each16571-8624f155186-d6ec-4160-b9a7-51943eb49e8512022-08-04
16571-862-09EA - Each16571-862b901f519-9729-4670-b6e8-193a370120ff12022-08-04
16571-862-12EA - Each16571-862d7f0faf3-7cab-4a68-96f1-08e032461e4912024-08-12
16571-862-50EA - Each16571-8628d87f2f8-d9de-4c07-be6f-b2b176658df712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-862BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 5 package rows20241114_e4f4d3fa-ddf6-4125-8486-8157efc095c1.zip

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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-862-031657108620330 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-03) 2022-08-010000-00-00NoNoCurrent
16571-862-091657108620990 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-09) 2022-08-010000-00-00NoNoCurrent
16571-862-10165710862101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-10) 2022-08-010000-00-00NoNoCurrent
16571-862-1216571086212120 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-12) 2024-06-03NoNoCurrent
16571-862-5016571086250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-50) 2022-08-010000-00-00NoNoCurrent