sertraline hydrochloride

Generic: sertraline hydrochloride

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

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler cipla usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 150 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-438
Product ID 69097-438_d93baba8-ca39-4dd5-bcda-5def49b56e2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218853
Listing Expiration 2026-12-31
Marketing Start 2025-07-17

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 69097438
Hyphenated Format 69097-438

Supplemental Identifiers

RxCUI
251201 410584
UPC
0369097438029
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 ANDA218853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (69097-438-02)
source: ndc

Packages (1)

69097-438-02 30 CAPSULE in 1 BOTTLE (69097-438-02)

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": "d93baba8-ca39-4dd5-bcda-5def49b56e2a", "openfda": {"upc": ["0369097438029"], "unii": ["UTI8907Y6X"], "rxcui": ["251201", "410584"], "spl_set_id": ["3a3efb5f-b24a-438d-9253-371ff3b5417d"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69097-438-02)", "package_ndc": "69097-438-02", "marketing_start_date": "20250717"}], "brand_name": "Sertraline Hydrochloride", "product_id": "69097-438_d93baba8-ca39-4dd5-bcda-5def49b56e2a", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69097-438", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA218853", "marketing_category": "ANDA", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}