Theophylline

Product NDC: 68151-0667
11-digit product format: 681510667
Labeler code: 68151
Product ID: 68151-0667_29fe6915-377d-4310-ad94-bf6144b849bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA087571
Marketing category: ANDA
Marketing start: 2012-02-02
Marketing end: 0000-00-00
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 400 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	68151-0667		I	Inactivated by FDA		2026-08-07
excluded package	package	68151-0667	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	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	68151-0667-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087571-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1982-09-01	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A087571-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1982-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087571-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1982-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087571-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1982-09-01	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087571-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A087571-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087571-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087571-001	AB	1	`ea99ee380514…`

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
68151-0667-0	2020-01-31	C162847	48780-1	9d75b9d0-e3cb-f424-e053-dadaa90a57ce	Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0667-0	TheophyllineAnhydrous	1 in 1 PACKAGE	TABLET, EXTENDED RELEASE	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0667	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_def63108-2e96-446c-a7a8-a65d54de2859.zip

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
313291	theophylline 400 MG Extended Release Oral Tablet	PSN	def63108-2e96-446c-a7a8-a65d54de2859	4
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	def63108-2e96-446c-a7a8-a65d54de2859	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0667-0	68151066700	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4