theophylline

Generic: theophylline

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler strides pharma science limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 450 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-244
Product ID 64380-244_86a861fa-5c70-432e-8c0b-6e7241af5e82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215312
Listing Expiration 2027-12-31
Marketing Start 2024-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380244
Hyphenated Format 64380-244

Supplemental Identifiers

RxCUI
314241 317769
UPC
0364380244011 0364380243014
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 theophylline (source: ndc)
Generic Name theophylline (source: ndc)
Application Number ANDA215312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-244-01)
source: ndc

Packages (1)

64380-244-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-244-01)

Ingredients (1)

theophylline anhydrous (450 mg/1)

Linked Drug Pages (1)

Theophylline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86a861fa-5c70-432e-8c0b-6e7241af5e82", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0364380244011", "0364380243014"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["b7a90ccf-9c32-40cc-9008-7e55b3da4dfd"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-244-01)", "package_ndc": "64380-244-01", "marketing_start_date": "20240927"}], "brand_name": "Theophylline", "product_id": "64380-244_86a861fa-5c70-432e-8c0b-6e7241af5e82", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "64380-244", "generic_name": "Theophylline", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "450 mg/1"}], "application_number": "ANDA215312", "marketing_category": "ANDA", "marketing_start_date": "20240927", "listing_expiration_date": "20271231"}