scopolamine

Generic: scopolamine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name scopolamine
Generic Name scopolamine
Labeler actavis pharma, inc.
Dosage Form SYSTEM
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1 mg/3d

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2258
Product ID 0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208769
Listing Expiration 2026-12-31
Marketing Start 2022-05-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05912258
Hyphenated Format 0591-2258

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 ANDA208769 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/3d
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • 24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • 10 POUCH in 1 CARTON (0591-2258-79) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
source: ndc

Packages (3)

0591-2258-04 4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 0591-2258-23 24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 0591-2258-79 10 POUCH in 1 CARTON (0591-2258-79) / 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": "59f10193-3604-4f3c-a9f7-68a55004f3d0", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["800b6421-48eb-47f5-b255-c12f75e59068"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (0591-2258-04)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "0591-2258-04", "marketing_start_date": "20220512"}, {"sample": false, "description": "24 POUCH in 1 CARTON (0591-2258-23)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "0591-2258-23", "marketing_start_date": "20220512"}, {"sample": false, "description": "10 POUCH in 1 CARTON (0591-2258-79)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "0591-2258-79", "marketing_start_date": "20220512"}], "brand_name": "scopolamine", "product_id": "0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0", "dosage_form": "SYSTEM", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0591-2258", "generic_name": "scopolamine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "scopolamine", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1 mg/3d"}], "application_number": "ANDA208769", "marketing_category": "ANDA", "marketing_start_date": "20220512", "listing_expiration_date": "20261231"}