Home NDC 62135-556-47 Theophylline
Product NDC 62135-556
Requested package NDC 62135-556-47
11-digit product format 621350556
Labeler code 62135
Product ID 62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA091156
Marketing category ANDA
Marketing start 2011-04-13
Substance THEOPHYLLINE ANHYDROUS
Active strength 80 mg/15mL
Pharmacologic classes Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091156-001 THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091156-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091156-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Theophylline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THEOPHYLLINE ANHYDROUS 80 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0I55128JYK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313306 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-556-24 Theophylline 2 in 1 BOX SOLUTION 2 4 62135-556-24 Theophylline 10 in 1 TRAY SOLUTION 10 4 62135-556-47 Theophylline 473 mL in 1 BOTTLE SOLUTION 473 4 62135-556-51 Theophylline 15 mL in 1 CUP SOLUTION 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-556 THEOPHYLLINE SOLUTION [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20240602_1b685384-5d96-46fa-b93b-e96538a2cfe7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62135-556-47 62135055647 473 mL in 1 BOTTLE (62135-556-47) 473 ml 2022-10-27 0000-00-00 No No Current