buPropion Hydrochloride

Product NDC
71765-002
11-digit product format
717650002
Labeler code
71765
Product ID
71765-002_98bf4e22-8ea2-9303-e053-2a95a90ad434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zhejiang Jutai Pharamceutical Co., Ltd
Application
ANDA211200
Marketing category
ANDA
Marketing start
2020-12-06
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
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71765-002IInactivated by FDA2026-09-14
excluded packagepackage71765-00271765-002-03IInactivated by FDA2026-09-14
excluded packagepackage71765-00271765-002-09IInactivated by FDA2026-09-14
excluded packagepackage71765-00271765-002-50IInactivated 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 2 · 76 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71765-002-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71765-002-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71765-002-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71765-002-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71765-002-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71765-002-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71765-002-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71765-002-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71765-002-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71765-002-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71765-002-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71765-002-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71765-002-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71765-002-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71765-002-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71765-002-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71765-002-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71765-002-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71765-002-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71765-002-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71765-002-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71765-002-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71765-002-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71765-002-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71765-002-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71765-002-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71765-002-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71765-002-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71765-002-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71765-002-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71765-002-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71765-002-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71765-002-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71765-002-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71765-002-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71765-002-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71765-002-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71765-002-098af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71765-002-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71765-002-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71765-002-09834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71765-002-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71765-002-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71765-002-091332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71765-002-501332a3947898…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
71765-002-03buPropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE309
71765-002-09buPropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE909
71765-002-50buPropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71765-002BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ZHEJIANG JUTAI PHARAMCEUTICAL CO., LTD]9Legacy NDC, 3 package rows20201206_1f25201c-1a15-4da1-a250-e91040df8774.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
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1f25201c-1a15-4da1-a250-e91040df87749
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1f25201c-1a15-4da1-a250-e91040df87749
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1f25201c-1a15-4da1-a250-e91040df87749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71765-002-037176500020330 in 1 BOTTLEHistorical
71765-002-097176500020990 in 1 BOTTLEHistorical
71765-002-5071765000250500 in 1 BOTTLEHistorical