FDA.reportPublic FDA data

Theophylline

Product NDC
62332-026
11-digit product format
623320026
Labeler code
62332
Product ID
62332-026_d9cbb2b7-6524-4587-9111-e3abfd2e888b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA090430
Marketing category
ANDA
Marketing start
2016-01-29
Substance
THEOPHYLLINE ANHYDROUS
Active strength
450 mg/1
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theophylline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS450 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0I55128JYK
Rxcui314241, 317769

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-026-30Theophylline30 in 1 BOTTLETABLET, EXTENDED RELEASE306
62332-026-31Theophylline100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
62332-026-71Theophylline500 in 1 BOTTLETABLET, EXTENDED RELEASE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-026-31EA - Each62332-02647f3f49d-1dc5-45ab-8e17-06bf7cf889d912016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-026THEOPHYLLINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20211008_77e849b8-900b-4f0d-ac5c-1391abcd5721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317769theophylline 300 MG Extended Release Oral TabletPSN77e849b8-900b-4f0d-ac5c-1391abcd57216
314241theophylline 450 MG Extended Release Oral TabletPSN77e849b8-900b-4f0d-ac5c-1391abcd57216
317769theophylline 300 MG Extended Release Oral TabletSCD77e849b8-900b-4f0d-ac5c-1391abcd57216
314241theophylline 450 MG Extended Release Oral TabletSCD77e849b8-900b-4f0d-ac5c-1391abcd57216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-026-306233200263030 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-30) 2016-01-290000-00-00NoNoCurrent
62332-026-3162332002631100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-31) 2016-01-290000-00-00NoNoCurrent
62332-026-7162332002671500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-026-71) 2016-01-290000-00-00NoNoCurrent