Theophylline

Product NDC: 50111-459
11-digit product format: 501110459
Labeler code: 50111
Product ID: 50111-459_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: ANDA089763
Marketing category: ANDA
Marketing start: 2010-09-13
Marketing end: 0000-00-00
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 300 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50111-459		D	Discontinued by firm	2026-08-07
excluded package	package	50111-459	50111-459-01	D	Discontinued by firm	2026-08-07
excluded package	package	50111-459	50111-459-02	D	Discontinued by firm	2026-08-07
excluded package	package	50111-459	50111-459-03	D	Discontinued by firm	2026-08-07

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50111-459-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50111-459-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50111-459-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50111-459-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50111-459-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50111-459-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50111-459-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50111-459-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50111-459-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50111-459-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50111-459-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50111-459-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50111-459-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50111-459-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50111-459-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50111-459-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50111-459-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50111-459-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50111-459-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50111-459-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50111-459-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50111-459-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50111-459-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50111-459-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50111-459-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50111-459-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50111-459-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50111-459-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50111-459-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50111-459-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50111-459-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50111-459-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50111-459-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50111-459-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50111-459-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50111-459-01	`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
A089763-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		1990-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A089763-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089763-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089763-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089763-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089763-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089763-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089763-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089763-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089763-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089763-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089763-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089763-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089763-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089763-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089763-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089763-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089763-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089763-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089763-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089763-001	AB	1	`bb7c543d1eb4…`
2019-12-14 00:12 UTC	2019-12	A089763-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089763-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089763-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089763-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089763-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089763-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089763-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089763-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089763-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089763-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089763-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089763-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089763-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089763-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089763-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089763-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089763-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1d07c79-5983-427d-b6f5-df0550dcc598	Product name	4	20250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2	Product name	1	20170302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-459-01	EA - Each	50111-459	478995e1-a96c-44ac-bbe7-d2d3a217754a	1	2012-07-24
50111-459-02	EA - Each	50111-459	5095b7da-a5a7-423e-acf3-44f44c7f1193	1	2012-07-24
50111-459-03	EA - Each	50111-459	c1ec2aa8-6790-4f06-b4ad-f8147f5a70ff	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	THEOPHYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
THEOPHYLLINE	ACTIVE INGREDIENT	C137DTR5RG	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE EXTENDED RELEASE (THEOPHYLLINE, ANHYDROUS) TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE 2208 (100000 MPA.S)	INACTIVE INGREDIENT	VM7F0B23ZI	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	AvKARE	f93e20b1-97aa-088d-e053-6394a90a25d4	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	9591d4db-2b88-4f0f-b61e-64ba67626e3d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763
Theophylline	THEOPHYLLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	701fbf9c-e06b-46f4-863b-981acf3021aa	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0I55128JYK	THEOPHYLLINE ANHYDROUS	58-55-9	THEOPHYLLINE ANHYDROUS
C137DTR5RG	THEOPHYLLINE	5967-84-0	Theophylline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237178	theophylline 100 MG Extended Release Oral Tablet	PSN	699a4e05-95cb-4b28-8927-d97a4afbf463	1
346574	theophylline 200 MG Extended Release Oral Tablet	PSN	699a4e05-95cb-4b28-8927-d97a4afbf463	1
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	699a4e05-95cb-4b28-8927-d97a4afbf463	1
237178	theophylline 100 MG Extended Release Oral Tablet	SCD	699a4e05-95cb-4b28-8927-d97a4afbf463	1
346574	theophylline 200 MG Extended Release Oral Tablet	SCD	699a4e05-95cb-4b28-8927-d97a4afbf463	1
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	699a4e05-95cb-4b28-8927-d97a4afbf463	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Extended-Release Tablets	Bryant Ranch Prepack	2017-07-05	HUMAN PRESCRIPTION DRUG LABEL	1003
Theophylline Extended-Release Tablets	Physicians Total Care, Inc.	2011-09-23	HUMAN PRESCRIPTION DRUG LABEL	1
Theophylline Extended-Release Tablets	NCS HealthCare of KY, Inc dba Vangard Labs	2010-07-29	HUMAN PRESCRIPTION DRUG LABEL	3