Theophylline

Product NDC
50111-482
11-digit product format
501110482
Labeler code
50111
Product ID
50111-482_7ead0af5-da03-4e84-8685-f469cfde4855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA089808
Marketing category
ANDA
Marketing start
2010-09-13
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
200 mg/1
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50111-482DDiscontinued by firm2026-08-17
excluded packagepackage50111-48250111-482-01DDiscontinued by firm2026-08-17
excluded packagepackage50111-48250111-482-02DDiscontinued by firm2026-08-17
excluded packagepackage50111-48250111-482-03DDiscontinued by firm2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50111-482-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50111-482-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50111-482-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50111-482-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50111-482-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50111-482-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50111-482-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50111-482-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50111-482-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50111-482-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50111-482-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50111-482-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50111-482-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50111-482-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50111-482-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50111-482-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50111-482-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50111-482-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50111-482-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50111-482-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50111-482-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50111-482-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50111-482-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50111-482-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50111-482-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50111-482-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50111-482-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50111-482-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50111-482-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50111-482-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50111-482-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50111-482-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50111-482-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50111-482-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50111-482-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50111-482-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089808-001THEOPHYLLINETHEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORALABRS1990-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089808-001THEOPHYLLINE200MGTABLET, EXTENDED RELEASE / ORAL1990-04-30e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089808-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089808-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A089808-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089808-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089808-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089808-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A089808-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089808-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-482-01EA - Each50111-4828347a4b3-3008-4aaf-b5e1-430d0fdd981512012-07-24
50111-482-02EA - Each50111-48235721f76-50e2-461c-b950-f5125bd03bd112012-07-24
50111-482-03EA - Each50111-4824d19d5fd-4ee5-4696-9fcb-8a2eb298a70112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZITHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETHEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
THEOPHYLLINEACTIVE INGREDIENTC137DTR5RGTHEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTHEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOTHEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZITHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTHEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237178theophylline 100 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
346574theophylline 200 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
317769theophylline 300 MG Extended Release Oral TabletPSN699a4e05-95cb-4b28-8927-d97a4afbf4631
237178theophylline 100 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631
346574theophylline 200 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631
317769theophylline 300 MG Extended Release Oral TabletSCD699a4e05-95cb-4b28-8927-d97a4afbf4631