theo-24

Generic: theophylline anhydrous

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

Drug Facts

Product Profile

Brand Name theo-24
Generic Name theophylline anhydrous
Labeler endo usa, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 200 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 52244-200
Product ID 52244-200_95d19693-50ba-43fc-81fe-6cddc537703a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087943
Listing Expiration 2026-12-31
Marketing Start 2014-08-25

Pharmacologic Class

Established (EPC)
methylxanthine [epc]
Chemical Structure
xanthines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52244200
Hyphenated Format 52244-200

Supplemental Identifiers

RxCUI
198264 313272 313310 701712 844590 844591 844813 844829
UNII
0I55128JYK
NUI
N0000175790 M0023046

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 theo-24 (source: ndc)
Generic Name theophylline anhydrous (source: ndc)
Application Number ANDA087943 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)
source: ndc

Packages (1)

Ingredients (1)

theophylline anhydrous (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "95d19693-50ba-43fc-81fe-6cddc537703a", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["198264", "313272", "313310", "701712", "844590", "844591", "844813", "844829"], "spl_set_id": ["7a108fa0-c230-475f-be93-6f864b98a410"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)", "package_ndc": "52244-200-10", "marketing_start_date": "20140825"}], "brand_name": "Theo-24", "product_id": "52244-200_95d19693-50ba-43fc-81fe-6cddc537703a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "52244-200", "generic_name": "theophylline anhydrous", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theo-24", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "200 mg/1"}], "application_number": "ANDA087943", "marketing_category": "ANDA", "marketing_start_date": "20140825", "listing_expiration_date": "20261231"}