Home NDC 0258-3638-01 NDC 0258-3638-01 - Theophylline This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 0258-3638
Requested NDC 0258-3638-01
Package NDCs from labels 0258-3638-01
Manufacturer Inwood Laboratories, Inc.
Effective date 2006-10-08
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0258-3638-01 Theophylline 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0258-3638 THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 1 package rows 20070726_9940057a-831f-4bdb-8741-d10c0ca24925.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Theophylline, anhydrous ACTIVE INGREDIENT 0I55128JYK THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 Theophylline, anhydrous ACTIVE MOIETY 0I55128JYK THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 black iron oxide INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 castor oil INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 ethylcellulose INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 methylparaben INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 pharmaceutical glaze INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 povidone INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 sodium propionate INACTIVE INGREDIENT DK6Y9P42IN THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 starch INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 sugar spheres INACTIVE INGREDIENT THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) CAPSULE, EXTENDED RELEASE [INWOOD LABORATORIES, INC.] 1
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Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.