scopolamine

Generic: scopolamine

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

Drug Facts

Product Profile

Brand Name scopolamine
Generic Name scopolamine
Labeler zydus pharmaceuticals usa inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1 mg/3d

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1846
Product ID 70710-1846_12f01688-9740-4229-b196-f51cff21a122
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217893
Listing Expiration 2026-12-31
Marketing Start 2024-09-05

Pharmacologic Class

Established (EPC)
anticholinergic [epc]
Mechanism of Action
cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101846
Hyphenated Format 70710-1846

Supplemental Identifiers

RxCUI
226552
UNII
DL48G20X8X
NUI
N0000175574 N0000175370

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 scopolamine (source: ndc)
Generic Name scopolamine (source: ndc)
Application Number ANDA217893 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/3d
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (70710-1846-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • 4 POUCH in 1 CARTON (70710-1846-4) / 1 PATCH in 1 POUCH (70710-1846-1) / 3 d in 1 PATCH
  • 24 POUCH in 1 CARTON (70710-1846-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
source: ndc

Packages (3)

70710-1846-2 10 POUCH in 1 CARTON (70710-1846-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 70710-1846-4 4 POUCH in 1 CARTON (70710-1846-4) / 1 PATCH in 1 POUCH (70710-1846-1) / 3 d in 1 PATCH 70710-1846-7 24 POUCH in 1 CARTON (70710-1846-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH

Ingredients (1)

scopolamine (1 mg/3d)

Linked Drug Pages (1)

Scopolamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "12f01688-9740-4229-b196-f51cff21a122", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["62d8332e-b8d2-4d13-8071-978d57e51928"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (70710-1846-2)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "70710-1846-2", "marketing_start_date": "20240905"}, {"sample": false, "description": "4 POUCH in 1 CARTON (70710-1846-4)  / 1 PATCH in 1 POUCH (70710-1846-1)  / 3 d in 1 PATCH", "package_ndc": "70710-1846-4", "marketing_start_date": "20240905"}, {"sample": false, "description": "24 POUCH in 1 CARTON (70710-1846-7)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "70710-1846-7", "marketing_start_date": "20240905"}], "brand_name": "Scopolamine", "product_id": "70710-1846_12f01688-9740-4229-b196-f51cff21a122", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70710-1846", "generic_name": "Scopolamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Scopolamine", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1 mg/3d"}], "application_number": "ANDA217893", "marketing_category": "ANDA", "marketing_start_date": "20240905", "listing_expiration_date": "20261231"}