sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 150 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1948
Product ID 70710-1948_55c2a9d1-6c98-4073-8532-b1f51aa2fda9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA220275
Listing Expiration 2027-12-31
Marketing Start 2026-01-29

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 707101948
Hyphenated Format 70710-1948

Supplemental Identifiers

RxCUI
251201 410584
UNII
UTI8907Y6X

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 sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA220275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (70710-1948-3)
source: ndc

Packages (1)

70710-1948-3 30 CAPSULE in 1 BOTTLE (70710-1948-3)

Ingredients (1)

sertraline hydrochloride (150 mg/1)

Linked Drug Pages (1)

Sertraline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "55c2a9d1-6c98-4073-8532-b1f51aa2fda9", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["251201", "410584"], "spl_set_id": ["23f1c8c5-032c-4ea9-beb0-ca3a614ba4b6"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (70710-1948-3)", "package_ndc": "70710-1948-3", "marketing_start_date": "20260129"}], "brand_name": "Sertraline Hydrochloride", "product_id": "70710-1948_55c2a9d1-6c98-4073-8532-b1f51aa2fda9", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70710-1948", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA220275", "marketing_category": "ANDA", "marketing_start_date": "20260129", "listing_expiration_date": "20271231"}