semglee

Generic: insulin glargine-yfgn

Labeler: biocon biologics inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name semglee
Generic Name insulin glargine-yfgn
Labeler biocon biologics inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin glargine 100 [iU]/mL

Manufacturer
Biocon Biologics Inc.

Identifiers & Regulatory

Product NDC 83257-012
Product ID 83257-012_0dcf2f70-92d9-c24b-9787-0d395e04b46f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761201
Listing Expiration 2026-12-31
Marketing Start 2023-07-28

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83257012
Hyphenated Format 83257-012

Supplemental Identifiers

RxCUI
2563971 2563973 2563976 2563977
UNII
2ZM8CX04RZ
NUI
M0011417 N0000175453

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 semglee (source: ndc)
Generic Name insulin glargine-yfgn (source: ndc)
Application Number BLA761201 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE
  • 5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE
source: ndc

Packages (2)

83257-012-31 1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE 83257-012-33 5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE

Ingredients (1)

insulin glargine (100 [iU]/mL)

Linked Drug Pages (1)

SEMGLEE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "0dcf2f70-92d9-c24b-9787-0d395e04b46f", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["2563971", "2563973", "2563976", "2563977"], "spl_set_id": ["8cf5544f-87d6-468b-f6ae-898b1fdb5d80"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (83257-012-31)  / 3 mL in 1 SYRINGE", "package_ndc": "83257-012-31", "marketing_start_date": "20230728"}, {"sample": false, "description": "5 SYRINGE in 1 CARTON (83257-012-33)  / 3 mL in 1 SYRINGE", "package_ndc": "83257-012-33", "marketing_start_date": "20230728"}], "brand_name": "SEMGLEE", "product_id": "83257-012_0dcf2f70-92d9-c24b-9787-0d395e04b46f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "83257-012", "generic_name": "insulin glargine-yfgn", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEMGLEE", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 [iU]/mL"}], "application_number": "BLA761201", "marketing_category": "BLA", "marketing_start_date": "20230728", "listing_expiration_date": "20261231"}