theophylline anhydrous

Generic: theophylline

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline anhydrous
Generic Name theophylline
Labeler rhodes pharmaceuticals l.p.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 400 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-701
Product ID 42858-701_5bbaf151-7dc4-4860-9e46-a2e85071c120
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040086
Listing Expiration 2026-12-31
Marketing Start 2012-02-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858701
Hyphenated Format 42858-701

Supplemental Identifiers

RxCUI
313291
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 anhydrous (source: ndc)
Generic Name theophylline (source: ndc)
Application Number ANDA040086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)
source: ndc

Packages (1)

42858-701-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)

Ingredients (1)

theophylline anhydrous (400 mg/1)

Linked Drug Pages (1)

Theophylline Anhydrous ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5bbaf151-7dc4-4860-9e46-a2e85071c120", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["313291"], "spl_set_id": ["bba266d2-1d22-49a9-b3db-e4f06802a8a9"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)", "package_ndc": "42858-701-01", "marketing_start_date": "20120202"}], "brand_name": "Theophylline Anhydrous", "product_id": "42858-701_5bbaf151-7dc4-4860-9e46-a2e85071c120", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "42858-701", "generic_name": "Theophylline", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "brand_name_suffix": "Anhydrous", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "400 mg/1"}], "application_number": "ANDA040086", "marketing_category": "ANDA", "marketing_start_date": "20120202", "listing_expiration_date": "20261231"}