divigel

Generic: estradiol

Labeler: vertical pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name divigel
Generic Name estradiol
Labeler vertical pharmaceuticals, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol 1.25 mg/1.25g

Manufacturer
Vertical Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 68025-086
Product ID 68025-086_077120b4-1172-49bc-b197-363f410589ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022038
Listing Expiration 2027-12-31
Marketing Start 2019-12-17

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68025086
Hyphenated Format 68025-086

Supplemental Identifiers

RxCUI
2619677 2619678 2619679 2619680 2619681 2619682 2619683 2619684 2619685 2619686
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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 divigel (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA022038 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1.25g
source: ndc
Packaging
  • 7 PACKET in 1 CARTON (68025-086-07) / 1.25 g in 1 PACKET
  • 30 PACKET in 1 CARTON (68025-086-30) / 1.25 g in 1 PACKET
source: ndc

Packages (2)

68025-086-07 7 PACKET in 1 CARTON (68025-086-07) / 1.25 g in 1 PACKET 68025-086-30 30 PACKET in 1 CARTON (68025-086-30) / 1.25 g in 1 PACKET

Ingredients (1)

estradiol (1.25 mg/1.25g)

Linked Drug Pages (1)

DIVIGEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "077120b4-1172-49bc-b197-363f410589ab", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619678", "2619679", "2619680", "2619681", "2619682", "2619683", "2619684", "2619685", "2619686"], "spl_set_id": ["59e610dc-883e-4f07-9ec6-a5841b0bf9fb"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Vertical Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 PACKET in 1 CARTON (68025-086-07)  / 1.25 g in 1 PACKET", "package_ndc": "68025-086-07", "marketing_start_date": "20191217"}, {"sample": false, "description": "30 PACKET in 1 CARTON (68025-086-30)  / 1.25 g in 1 PACKET", "package_ndc": "68025-086-30", "marketing_start_date": "20191217"}], "brand_name": "DIVIGEL", "product_id": "68025-086_077120b4-1172-49bc-b197-363f410589ab", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68025-086", "generic_name": "estradiol", "labeler_name": "Vertical Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIVIGEL", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1.25 mg/1.25g"}], "application_number": "NDA022038", "marketing_category": "NDA", "marketing_start_date": "20191217", "listing_expiration_date": "20271231"}