Home NDC 0264-9554-10 Theophylline in Dextrose
Product NDC 0264-9554
Requested package NDC 0264-9554-10
11-digit product format 002649554
Labeler code 0264
Product ID 0264-9554_5df8f4d8-1afb-48e9-9175-768cf77c3064
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline Anhydrous and Dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA019826
Marketing category NDA
Marketing start 1992-08-14
Marketing end 0000-00-00
Substance THEOPHYLLINE ANHYDROUS; DEXTROSE MONOHYDRATE
Active strength 80 mg/100mL; g/100mL
Pharmacologic classes Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 200MG/100ML INJECTABLE / INJECTION 1992-08-14 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 400MG/100ML INJECTABLE / INJECTION 1992-08-14 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14
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 7 · 258 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 2026-09-14 22:38:34 2026-08 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-005 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML INJECTABLE / INJECTION 1992-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019826-006 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019826-001 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019826-002 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019826-003 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION RLD 1992-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019826-004 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML INJECTABLE / INJECTION 1992-08-14 b8a1b40f171c…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-9554 THEOPHYLLINE IN DEXTROSE (THEOPHYLLINE ANHYDROUS AND DEXTROSE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 12 Legacy NDC 20170818_c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-9554-10 00264955410 24 CONTAINER in 1 CASE (0264-9554-10) > 500 mL in 1 CONTAINER 24 container 1992-08-14 0000-00-00 No No Current