fluoxetine

Generic: fluoxetine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler chartwell rx, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-730
Product ID 62135-730_4a16df46-6bfb-37c2-e063-6394a90a9525
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076458
Listing Expiration 2027-12-31
Marketing Start 2004-05-14

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135730
Hyphenated Format 62135-730

Supplemental Identifiers

RxCUI
310386
UPC
0362135730413
UNII
I9W7N6B1KJ

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 fluoxetine (source: ndc)
Generic Name fluoxetine (source: ndc)
Application Number ANDA076458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45)
  • 120 mL in 1 BOTTLE (62135-730-41)
source: ndc

Packages (2)

62135-730-24 2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45) 62135-730-41 120 mL in 1 BOTTLE (62135-730-41)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a16df46-6bfb-37c2-e063-6394a90a9525", "openfda": {"upc": ["0362135730413"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["cac17277-3481-4661-935f-efc48fff534c"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-730-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45)", "package_ndc": "62135-730-24", "marketing_start_date": "20240523"}, {"sample": false, "description": "120 mL in 1 BOTTLE (62135-730-41)", "package_ndc": "62135-730-41", "marketing_start_date": "20230927"}], "brand_name": "Fluoxetine", "product_id": "62135-730_4a16df46-6bfb-37c2-e063-6394a90a9525", "dosage_form": "LIQUID", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62135-730", "generic_name": "Fluoxetine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA076458", "marketing_category": "ANDA", "marketing_start_date": "20040514", "listing_expiration_date": "20271231"}