FDA.reportPublic FDA data

Theophylline

Product NDC
29033-002
11-digit product format
290330002
Labeler code
29033
Product ID
29033-002_cc6d208a-826c-4aae-a78e-da1a91c60699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA040560
Marketing category
ANDA
Marketing start
2020-01-23
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
600 mg/1
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29033-002-012026-01-29C16284748780-149896155-bf89-586f-e063-e6dba90add90Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29033-002-01Theophylline(Anhydrous)100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29033-002-01EA - Each29033-002bdf67cde-4ddb-49e8-925e-0b2e7ebd8c9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]2
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]2
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29033-002THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]6Legacy NDC, 1 package rows20211103_038c2b07-8028-4dc4-847c-adafe1b0e81a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313291theophylline 400 MG Extended Release Oral TabletPSN038c2b07-8028-4dc4-847c-adafe1b0e81a6
348472theophylline 600 MG Extended Release Oral TabletPSN038c2b07-8028-4dc4-847c-adafe1b0e81a6
313291theophylline 400 MG Extended Release Oral TabletSCD038c2b07-8028-4dc4-847c-adafe1b0e81a6
348472theophylline 600 MG Extended Release Oral TabletSCD038c2b07-8028-4dc4-847c-adafe1b0e81a6
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
348472theophylline 600 MG Extended Release Oral TabletPSNc88d2f3e-3478-4ed4-b4da-44dece7818e93
348472theophylline 600 MG Extended Release Oral TabletSCDc88d2f3e-3478-4ed4-b4da-44dece7818e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29033-002-0129033000201100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-002-01) 2020-01-230000-00-00NoNoCurrent