fluoxetine

Generic: fluoxetine

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

Drug Facts

Product Profile

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

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC

Identifiers & Regulatory

Product NDC 68999-730
Product ID 68999-730_4a935e59-bd47-9aae-e063-6394a90aad58
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 68999730
Hyphenated Format 68999-730

Supplemental Identifiers

RxCUI
310386
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 (68999-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-730-45)
source: ndc

Packages (1)

68999-730-24 2 TRAY in 1 BOX (68999-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-730-45)

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": "4a935e59-bd47-9aae-e063-6394a90aad58", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["d34362ed-e821-4c55-9f8c-3dfb772b1b2a"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-730-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-730-45)", "package_ndc": "68999-730-24", "marketing_start_date": "20251031"}], "brand_name": "Fluoxetine", "product_id": "68999-730_4a935e59-bd47-9aae-e063-6394a90aad58", "dosage_form": "LIQUID", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68999-730", "generic_name": "Fluoxetine", "labeler_name": "Chartwell Governmental & Specialty 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"}