Home NDC 60687-258 Theophylline
Product NDC 60687-258
11-digit product format 606870258
Labeler code 60687
Product ID 60687-258_b028a97b-7544-5695-e053-2995a90a991d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form SOLUTION
Route ORAL
Labeler American Health Packaging
Application ANDA091156
Marketing category ANDA
Marketing start 2017-03-31
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60687-258-71 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60687-258-71 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60687-258-71 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60687-258-71 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60687-258-71 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60687-258-71 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60687-258-71 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60687-258-71 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60687-258-71 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60687-258-71 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60687-258-71 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60687-258-71 557ba5c1ecfa…9c80585c8c6e…
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.
Product history page 1 of 2 · 41 observed 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 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091156-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA RS 2011-04-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-258-71 60687025871 5 TRAY in 1 CASE (60687-258-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-258-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-258-44) 5 tray 2017-03-31 0000-00-00 No No Current