FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
68180-320
11-digit product format
681800320
Labeler code
68180
Product ID
68180-320_8d23974b-fc5c-40bd-8383-a92ee065dfed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090693
Marketing category
ANDA
Marketing start
2017-06-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-320-02Bupropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE50023
68180-320-06Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE3023
68180-320-09Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-320-02EA - Each68180-3208f47fe55-c836-4952-9d0d-1c3cb123da1312017-07-07
68180-320-06EA - Each68180-3201c069b52-7e31-4022-b5d3-7c3f5938cc0012017-07-07
68180-320-09EA - Each68180-32070f25ac8-3a54-4821-90a2-57a13d2e1b7612017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-320BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 3 package rows20250510_1af14d2e-c64d-44b7-a402-8869e8e30661.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN1af14d2e-c64d-44b7-a402-8869e8e3066123
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1af14d2e-c64d-44b7-a402-8869e8e3066123
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1af14d2e-c64d-44b7-a402-8869e8e3066123
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1af14d2e-c64d-44b7-a402-8869e8e3066123
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY1af14d2e-c64d-44b7-a402-8869e8e3066123
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1af14d2e-c64d-44b7-a402-8869e8e3066123
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa0fdfc21-165a-43fa-9b3c-e48f3b8922509
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa0fdfc21-165a-43fa-9b3c-e48f3b8922509
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa0fdfc21-165a-43fa-9b3c-e48f3b8922509
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNbcbef1b4-a135-4231-bc65-7d0b335260e85
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDbcbef1b4-a135-4231-bc65-7d0b335260e85
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYaa3d3e5b-74a3-47f6-b9aa-d6e248e950e55
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYbcbef1b4-a135-4231-bc65-7d0b335260e85
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN8dab6d17-bf41-4a28-90db-b66959c0e1432
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8dab6d17-bf41-4a28-90db-b66959c0e1432
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNeee88553-acff-4bdd-acd1-f39bcb6fcdca2
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8dab6d17-bf41-4a28-90db-b66959c0e1432
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8dab6d17-bf41-4a28-90db-b66959c0e1432
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDeee88553-acff-4bdd-acd1-f39bcb6fcdca2
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY8dab6d17-bf41-4a28-90db-b66959c0e1432
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYeee88553-acff-4bdd-acd1-f39bcb6fcdca2
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8dab6d17-bf41-4a28-90db-b66959c0e1432
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN2f9c5162-a6c5-e362-e063-6294a90a198d1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN45789ff4-af5d-96b0-e063-6394a90a06441
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN2f9c5162-a6c5-e362-e063-6294a90a198d1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN0415ee03-30e4-e975-e063-6294a90abf3c1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD2f9c5162-a6c5-e362-e063-6294a90a198d1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD45789ff4-af5d-96b0-e063-6394a90a06441
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD2f9c5162-a6c5-e362-e063-6294a90a198d1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD0415ee03-30e4-e975-e063-6294a90abf3c1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY2f9c5162-a6c5-e362-e063-6294a90a198d1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY45789ff4-af5d-96b0-e063-6394a90a06441
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY2f9c5162-a6c5-e362-e063-6294a90a198d1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY0415ee03-30e4-e975-e063-6294a90abf3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-320-0268180032002500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-320-02) 2017-06-140000-00-00NoNoCurrent
68180-320-066818003200630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-320-06) 2017-06-140000-00-00NoNoCurrent
68180-320-096818003200990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-320-09) 2017-06-140000-00-00NoNoCurrent