BUPROPION HYDROCHLORIDE

Product NDC
70518-2772
Requested package NDC
70518-2772-0
11-digit product format
705182772
Labeler code
70518
Product ID
70518-2772_ea377fc4-90aa-de89-e053-2a95a90a4dfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210497
Marketing category
ANDA
Marketing start
2020-06-08
Marketing end
0000-00-00
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
2023-12-31
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 packagepackage70518-277270518-2772-0DDiscontinued by firm2026-08-03

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 · 11 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…

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
A210497-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31
A210497-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210497-001AB3
A210497-002AB3

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 UTC2026-02A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210497-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A210497-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-10-31782e0a99824c…

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 UTC2026-02A210497-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210497-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210497-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210497-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210497-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210497-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210497-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210497-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210497-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210497-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210497-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210497-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210497-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210497-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210497-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210497-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210497-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210497-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210497-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210497-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210497-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210497-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210497-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210497-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210497-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210497-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210497-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210497-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210497-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210497-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210497-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210497-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210497-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210497-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210497-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210497-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210497-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210497-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210497-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A210497-002AB31782e0a99824c…

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2772-2EA - Each70518-2772bf1bc540-73f4-4731-94d1-43b28af4d70312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2772BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]11Legacy NDC20250403_e187f83e-ee5e-46d9-9b4f-7e818d16776d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEREMEDYREPACK INC.080853c0-fcab-4645-9ddc-4946e895ac5f2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack82bcdd72-9146-4c8d-a8aa-f920158646052026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.42e228a2-25b3-44a6-8da7-6616ca44ac7f2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3bcdf7-d7f3-4f07-8113-af08af20a0d42026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAccord Healthcare Inc.34686e9d-c106-4276-8b47-7460cca8860e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.5dec4414-5595-46c9-ada9-3fbe981520402025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8af7829-8b61-6785-e053-6294a90af0522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29a6c6e3-f30f-6541-e063-6394a90ae11d2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEQuality Care Products, LLCa225dbbb-86f0-4547-a1c8-68eb64cd68922024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBluePoint Laboratories5ccec958-998d-43a1-86fb-eb2b5e697b772024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack7c46d95a-26f6-4364-8197-9e564e3405f22024-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutionsa18b5460-fcbb-42dd-8b87-197d11a089282024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutions77b78d35-40f5-4713-8468-aa09a6c2925d2024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEProficient Rx LP5d40e301-7e06-4ecd-b7c6-3d7ac6a134d22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEProficient Rx LP42201f4a-8856-4499-8bc3-d18612b1ec342022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210497
application number: ANDA210497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2772-07051827720090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2772-0) 2020-06-080000-00-00NoNoCurrent