bupropion hydrochloride (xl)

Generic: bupropion hydrochloride

Labeler: cipla usa inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)
Generic Name bupropion hydrochloride
Labeler cipla usa inc.,
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
CIPLA USA INC.,

Identifiers & Regulatory

Product NDC 69097-876
Product ID 69097-876_6fb20e45-74e9-4038-9db0-9eaf24b5560a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206556
Listing Expiration 2026-12-31
Marketing Start 2016-08-29

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 69097876
Hyphenated Format 69097-876

Supplemental Identifiers

RxCUI
993541 993557
UPC
0369097875022 0369097876029
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 (xl) (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA206556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-02)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-12)
source: ndc

Packages (2)

69097-876-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-02) 69097-876-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-12)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6fb20e45-74e9-4038-9db0-9eaf24b5560a", "openfda": {"upc": ["0369097875022", "0369097876029"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["c2cf79d7-1aba-4391-980b-5e218781f7c6"], "manufacturer_name": ["CIPLA USA INC.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-02)", "package_ndc": "69097-876-02", "marketing_start_date": "20160829"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-876-12)", "package_ndc": "69097-876-12", "marketing_start_date": "20160829"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "69097-876_6fb20e45-74e9-4038-9db0-9eaf24b5560a", "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": "69097-876", "generic_name": "bupropion hydrochloride", "labeler_name": "CIPLA USA INC.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA206556", "marketing_category": "ANDA", "marketing_start_date": "20160829", "listing_expiration_date": "20261231"}