sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sertraline hydrochloride 20 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8774
Product ID 63629-8774_10bafc5f-baec-4659-93f8-b0973a59304c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076934
Listing Expiration 2026-12-31
Marketing Start 2006-06-30

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298774
Hyphenated Format 63629-8774

Supplemental Identifiers

RxCUI
861064
UNII
UTI8907Y6X

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 sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA076934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

63629-8774-1 1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

sertraline hydrochloride (20 mg/mL)

Linked Drug Pages (1)

SERTRALINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10bafc5f-baec-4659-93f8-b0973a59304c", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["861064"], "spl_set_id": ["fa260c6c-9f6a-46a3-91ce-5665739d87e7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "63629-8774-1", "marketing_start_date": "20240404"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "63629-8774_10bafc5f-baec-4659-93f8-b0973a59304c", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-8774", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA076934", "marketing_category": "ANDA", "marketing_start_date": "20060630", "listing_expiration_date": "20261231"}