BUPROPION HYDROCHLORIDE (SR)

Product NDC
69097-877
11-digit product format
690970877
Labeler code
69097
Product ID
69097-877_a9b85841-5a69-4df1-a22d-3d4cf174e9a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA Inc.,
Application
ANDA206674
Marketing category
ANDA
Marketing start
2016-07-25
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE (SR)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

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
69097-877-02BUPROPION HYDROCHLORIDE (SR)30 in 1 BOTTLETABLET, EXTENDED RELEASE303
69097-877-03BUPROPION HYDROCHLORIDE (SR)60 in 1 BOTTLETABLET, EXTENDED RELEASE603
69097-877-07BUPROPION HYDROCHLORIDE (SR)100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
69097-877-12BUPROPION HYDROCHLORIDE (SR)500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-877BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CIPLA USA INC.,]3Current NDC, Legacy NDC, 4 package rows20181222_9d2c209b-248e-4e26-9cde-fe0abe4428c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNc9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f23
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN9d2c209b-248e-4e26-9cde-fe0abe4428c13
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN9d2c209b-248e-4e26-9cde-fe0abe4428c13
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN9d2c209b-248e-4e26-9cde-fe0abe4428c13
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDc9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f23
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD9d2c209b-248e-4e26-9cde-fe0abe4428c13
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9d2c209b-248e-4e26-9cde-fe0abe4428c13
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD9d2c209b-248e-4e26-9cde-fe0abe4428c13
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYc9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f23
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY9d2c209b-248e-4e26-9cde-fe0abe4428c13
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY9d2c209b-248e-4e26-9cde-fe0abe4428c13
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY9d2c209b-248e-4e26-9cde-fe0abe4428c13
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN72061450-5714-acb4-e053-2a95a90a0a991
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN538a0be1-8eab-4f8b-b967-30b9afdd76551
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD538a0be1-8eab-4f8b-b967-30b9afdd76551
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD72061450-5714-acb4-e053-2a95a90a0a991
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY72061450-5714-acb4-e053-2a95a90a0a991
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY538a0be1-8eab-4f8b-b967-30b9afdd76551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-877-026909708770230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-02) 2016-07-250000-00-00NoNoCurrent
69097-877-036909708770360 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-03) 2016-07-250000-00-00NoNoCurrent
69097-877-0769097087707100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-07) 2016-07-250000-00-00NoNoCurrent
69097-877-1269097087712500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-12) 2016-07-250000-00-00NoNoCurrent