Home NDC 54838-556-80 Theophylline
Product NDC 54838-556
Requested package NDC 54838-556-80
11-digit product format 548380556
Labeler code 54838
Product ID 54838-556_a2b8caa4-4d41-424e-9e92-f8fb4c86c11b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA091156
Marketing category ANDA
Marketing start 2011-04-13
Marketing end 2024-02-29
Substance THEOPHYLLINE ANHYDROUS
Active strength 80 mg/15mL
Pharmacologic classes Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded THEOPHYLLINE ANHYDROUS ACTIVE INGREDIENT 0I55128JYK THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 THEOPHYLLINE ANHYDROUS ACTIVE MOIETY 0I55128JYK THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R THEOPHYLLINE SOLUTION [SILARX PHARMACEUTICALS, INC] 9
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 54838-556-80 54838055680 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) 473 ml 2011-04-13 2024-02-29 No No Current