Home NDC 0121-0820 THEOPHYLLINE
Product NDC 0121-0820
11-digit product format 001210820
Labeler code 0121
Product ID 0121-0820_895f63e5-665b-4227-8e44-6971ba5ce294
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name THEOPHYLLINE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA206344
Marketing category ANDA
Marketing start 2016-12-16
Substance THEOPHYLLINE
Active strength 80 mg/15mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206344-001 THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL RS 2016-12-16
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 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL RS 2016-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206344-001 THEOPHYLLINE 80MG/15ML SOLUTION, ELIXIR / ORAL AA 2016-12-16 cb3db0bc1861…
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 80 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C137DTR5RG 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 0121-0820-04 THEOPHYLLINE 118 mL in 1 BOTTLE SOLUTION 118 9 0121-0820-16 THEOPHYLLINE 473 mL in 1 BOTTLE SOLUTION 473 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0820 THEOPHYLLINE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 9 Current NDC, Legacy NDC, 2 package rows 20241121_32b9780f-c46f-4e0f-9641-2cab60600e6e.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 Units Marketing start Marketing end Sample Exclude flag Status 0121-0820-04 00121082004 118 mL in 1 BOTTLE (0121-0820-04) 118 ml 2016-12-16 0000-00-00 No No Current 0121-0820-16 00121082016 473 mL in 1 BOTTLE (0121-0820-16) 473 ml 2016-12-16 0000-00-00 No No Current