Home NDC 52244-300 Theo-24
Product NDC 52244-300
11-digit product format 522440300
Labeler code 52244
Product ID 52244-300_95d19693-50ba-43fc-81fe-6cddc537703a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name theophylline anhydrous
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler ENDO USA, Inc.
Application ANDA087944
Marketing category ANDA
Marketing start 2014-08-25
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 .
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 ea99ee380514…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087944-001 THEO-24 300MG CAPSULE, EXTENDED RELEASE / ORAL 1983-08-22 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Theo-24
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198264 Internal RxNorm lookup 313272 Internal RxNorm lookup 313310 Internal RxNorm lookup 701712 Internal RxNorm lookup 844590 Internal RxNorm lookup 844591 Internal RxNorm lookup 844813 Internal RxNorm lookup 844829 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 52244-300-10 Theo-24 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52244-300 THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ENDO USA, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240709_7a108fa0-c230-475f-be93-6f864b98a410.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52244-300-10 52244030010 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-300-10) 2014-08-25 0000-00-00 No No Current