Theophylline

Product NDC: 68151-1393
11-digit product format: 681511393
Labeler code: 68151
Product ID: 68151-1393_7fe01ca0-e1e8-4402-9e7e-60c263cbc610
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA090430
Marketing category: ANDA
Marketing start: 2016-01-29
Marketing end: 0000-00-00
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 300 mg/1
Pharmacologic classes: Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-1393		I	Inactivated by FDA		2026-08-07
excluded package	package	68151-1393	68151-1393-1	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-1393-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-1393-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-1393-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-1393-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-1393-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-1393-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-1393-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-1393-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-1393-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-1393-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-1393-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-1393-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-1393-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-1393-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-1393-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-1393-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-1393-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-1393-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-1393-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-1393-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-1393-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-1393-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090430-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27
A090430-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090430-001	AB
A090430-002	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 3 · 82 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	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL		RS	2010-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090430-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090430-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090430-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090430-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090430-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090430-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090430-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090430-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090430-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090430-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090430-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090430-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090430-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090430-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090430-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090430-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090430-002	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A090430-001	AB	1	`3f01610625f2…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-1393-1	2020-01-31	C162847	48780-1	9d75b9cf-ec39-f424-e053-dadaa90a57ce	Theophylline Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-1393-1	Theophylline	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-1393	THEOPHYLLINE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20171228_6bc8923e-b7db-40a5-b22a-a975ca2bf1fd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Limited	31f3c720-1597-4d43-9296-33017b90b15f	2023-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090430 application number: ANDA090430
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Inc.	77e849b8-900b-4f0d-ac5c-1391abcd5721	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090430 application number: ANDA090430

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
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	6bc8923e-b7db-40a5-b22a-a975ca2bf1fd	2
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	6bc8923e-b7db-40a5-b22a-a975ca2bf1fd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-1393-1	68151139301	1 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Extended-Release Tablets Rx only	Carilion Materials Management	2017-12-28	Human Prescription Drug Label	2