FDA.reportPublic FDA data

Theophylline

Product NDC
10135-604
11-digit product format
101350604
Labeler code
10135
Product ID
10135-604_d21b83e5-364a-44c4-ae8c-a371ff5aeb22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline Anhydrous
Dosage form
SOLUTION
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA091156
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-604-082021-01-29C16284748780-1ba0f9c33-2a25-a910-e053-dadaa90a0b85Theophylline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-604-08Theophylline473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-604-08ML - Milliliter10135-604189ac122-4323-4f41-bdea-80582a40dfbe12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-604THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20191112_02fcc06e-2a81-404f-a7cd-313fcb0d833c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN02fcc06e-2a81-404f-a7cd-313fcb0d833c2
313306theophylline 5.33 MG/ML Oral SolutionSCD02fcc06e-2a81-404f-a7cd-313fcb0d833c2
313306theophylline 100 MG per 18.75 ML Oral SolutionSY02fcc06e-2a81-404f-a7cd-313fcb0d833c2
313306theophylline 80 MG per 15 ML Oral SolutionSY02fcc06e-2a81-404f-a7cd-313fcb0d833c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10135-604-0810135060408473 mL in 1 BOTTLE, PLASTIC473 mlHistorical