bupropion hydrochloride (sr) (69097-877)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (sr)

Generic Name bupropion hydrochloride

Labeler cipla usa inc.,

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer

Cipla USA Inc.,

Identifiers & Regulatory

Product NDC 69097-877

Product ID 69097-877_a9b85841-5a69-4df1-a22d-3d4cf174e9a6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206674

Listing Expiration 2026-12-31

Marketing Start 2016-07-25

Pharmacologic Class

Classes

aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097877

Hyphenated Format 69097-877

Supplemental Identifiers

RxCUI

993503 993518 993536

UPC

0369097879037 0369097878030 0369097877033

UNII

ZG7E5POY8O

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bupropion hydrochloride (sr) (source: ndc)

Generic Name bupropion hydrochloride (source: ndc)

Application Number ANDA206674 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-02)
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-03)
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-07)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-12)

source: ndc

Packages (4)

69097-877-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-02) 69097-877-03 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-03) 69097-877-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-07) 69097-877-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-12)

Ingredients (1)

bupropion hydrochloride (100 mg/1)

Linked Drug Pages (1)

BUPROPION HYDROCHLORIDE (SR) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a9b85841-5a69-4df1-a22d-3d4cf174e9a6", "openfda": {"upc": ["0369097879037", "0369097878030", "0369097877033"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["9d2c209b-248e-4e26-9cde-fe0abe4428c1"], "manufacturer_name": ["Cipla USA Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-02)", "package_ndc": "69097-877-02", "marketing_start_date": "20160725"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-03)", "package_ndc": "69097-877-03", "marketing_start_date": "20160725"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-07)", "package_ndc": "69097-877-07", "marketing_start_date": "20160725"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-877-12)", "package_ndc": "69097-877-12", "marketing_start_date": "20160725"}], "brand_name": "BUPROPION HYDROCHLORIDE (SR)", "product_id": "69097-877_a9b85841-5a69-4df1-a22d-3d4cf174e9a6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "69097-877", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Cipla USA Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPROPION HYDROCHLORIDE (SR)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA206674", "marketing_category": "ANDA", "marketing_start_date": "20160725", "listing_expiration_date": "20261231"}