Theophylline

Product NDC
51407-319
11-digit product format
514070319
Labeler code
51407
Product ID
51407-319_1041830e-393c-1772-e063-6394a90a7d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040560
Marketing category
ANDA
Marketing start
2006-04-21
Marketing end
2027-07-31
Substance
THEOPHYLLINE ANHYDROUS
Active strength
600 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
Brand name suffix
(Anhydrous)

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0I55128JYK
Rxcui313291, 348472

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
51407-319-01Theophylline(Anhydrous)100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-319-01EA - Each51407-3199ec7c381-8d16-4899-8672-3adfd1b2e7c712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-319THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20240201_aa80b9f4-8a5d-3e14-e053-2a95a90a8aab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313291theophylline 400 MG Extended Release Oral TabletPSNaa80b9f4-8a5d-3e14-e053-2a95a90a8aab5
348472theophylline 600 MG Extended Release Oral TabletPSNaa80b9f4-8a5d-3e14-e053-2a95a90a8aab5
313291theophylline 400 MG Extended Release Oral TabletSCDaa80b9f4-8a5d-3e14-e053-2a95a90a8aab5
348472theophylline 600 MG Extended Release Oral TabletSCDaa80b9f4-8a5d-3e14-e053-2a95a90a8aab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-319-0151407031901100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-319-01) 2020-01-300000-00-00NoNoCurrent