emtricitabine

Generic: emtricitabine

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

Drug Facts

Product Profile

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

emtricitabine 200 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-642
Product ID 69097-642_ac668220-d696-48b3-86f7-05509ba90805
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091168
Listing Expiration 2026-12-31
Marketing Start 2020-08-31

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097642
Hyphenated Format 69097-642

Supplemental Identifiers

RxCUI
403875
UNII
G70B4ETF4S
NUI
N0000175462 M0015066 N0000009947

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 emtricitabine (source: ndc)
Generic Name emtricitabine (source: ndc)
Application Number ANDA091168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (69097-642-02)
  • 1000 CAPSULE in 1 BOTTLE (69097-642-15)
source: ndc

Packages (2)

69097-642-02 30 CAPSULE in 1 BOTTLE (69097-642-02) 69097-642-15 1000 CAPSULE in 1 BOTTLE (69097-642-15)

Ingredients (1)

emtricitabine (200 mg/1)

Linked Drug Pages (1)

emtricitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac668220-d696-48b3-86f7-05509ba90805", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S"], "rxcui": ["403875"], "spl_set_id": ["a229c922-58eb-4795-9219-6cebb1779e35"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69097-642-02)", "package_ndc": "69097-642-02", "marketing_start_date": "20200831"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (69097-642-15)", "package_ndc": "69097-642-15", "marketing_start_date": "20200831"}], "brand_name": "emtricitabine", "product_id": "69097-642_ac668220-d696-48b3-86f7-05509ba90805", "dosage_form": "CAPSULE", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "69097-642", "generic_name": "emtricitabine", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "emtricitabine", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}], "application_number": "ANDA091168", "marketing_category": "ANDA", "marketing_start_date": "20200831", "listing_expiration_date": "20261231"}