Theophylline

Product NDC
50111-483
11-digit product format
501110483
Labeler code
50111
Product ID
50111-483_7ead0af5-da03-4e84-8685-f469cfde4855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA089807
Marketing category
ANDA
Marketing start
2010-09-13
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
100 mg/1
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-483-01EA - Each50111-483f6968f94-7b62-4a7a-84f7-f02c339f098a12012-07-24
50111-483-02EA - Each50111-48384996683-1ef6-42da-832a-5a43e55b4db712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE MOIETYN91BDP6H0XSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZISENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSENOPHYLLINE (THEOPHYLLINE ANHYDROUS, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZITHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198255theophylline 100 MG Oral CapsulePSN39d936d1-29a7-48b6-9327-94f2028012e78
198255theophylline 100 MG Oral CapsuleSCD39d936d1-29a7-48b6-9327-94f2028012e78
237178theophylline 100 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
346574theophylline 200 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
317769theophylline 300 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
237178theophylline 100 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631
346574theophylline 200 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631
317769theophylline 300 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631