Home NDC 72578-173 Theophylline
Product NDC 72578-173
11-digit product format 725780173
Labeler code 72578
Product ID 72578-173_1e5a0f45-86aa-498a-9cc3-9f7acc210ed6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA218063
Marketing category ANDA
Marketing start 2024-05-25
Substance THEOPHYLLINE ANHYDROUS
Active strength 300 mg/1
Pharmacologic classes Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218063-001 THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 A218063-002 THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-02-19 14:30 UTC 2026-02 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218063-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218063-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-05-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Theophylline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THEOPHYLLINE ANHYDROUS 300 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314241 Internal RxNorm lookup 317769 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 72578-173-01 Theophylline 100 in 1 BOTTLE TABLET, EXTENDED RELEASE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-173 THEOPHYLLINE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC] 1 Current NDC, 1 package rows 20240528_abdfb9b9-9402-4761-9347-8eb1c4d86242.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72578-173-01 72578017301 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-173-01) 2024-05-25 No No Current