Home NDC 17856-0038 Theophylline
Product NDC 17856-0038
11-digit product format 178560038
Labeler code 17856
Product ID 17856-0038_4524c143-c24e-c35b-e063-6394a90acc56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA091586
Marketing category ANDA
Marketing start 2012-08-02
Substance THEOPHYLLINE ANHYDROUS
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 17856-0038 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0038 17856-0038-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A091586-001 THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091586-001 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 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091586-001 THEOPHYLLINE 80MG/15ML SOLUTION / ORAL AA 2012-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Theophylline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THEOPHYLLINE ANHYDROUS 80 mg/15mL
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 · 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0038-1 Theophylline 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 5 17856-0038-1 Theophylline 50 in 1 BOX, UNIT-DOSE SOLUTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0038 THEOPHYLLINE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20250529_47e484c2-f59e-4a71-bb97-c90f128ac345.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 · 4 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 17856-0038-1 17856003801 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) / 15 mL in 1 CUP, UNIT-DOSE 2024-05-09 0000-00-00 No No Current