Theophylline

Product NDC: 69367-414
11-digit product format: 693670414
Labeler code: 69367
Product ID: 69367-414_46766222-63b4-478f-aa8b-a23b20476317
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline Anhydrous
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA040560
Marketing category: ANDA
Marketing start: 2025-11-25
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 400 mg/1
Pharmacologic classes: Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A040560-002	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21
A040560-003	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040560-002	AB
A040560-003	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	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040560-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Theophylline
Brand name suffix: (Anhydrous)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0I55128JYK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313291	Internal RxNorm lookup
348472	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04f1d1da-ce61-45b3-acf4-903cc81d16da	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69367-414-01	Theophylline(Anhydrous)	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-414-01	EA - Each	69367-414	20cd0389-55c7-45e2-9432-cb1fc6dd5e29	1	2026-02-05

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 (Anhydrous)	THEOPHYLLINE	Golden State Medical Supply, Inc.	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560
Theophylline (Anhydrous)	THEOPHYLLINE ANHYDROUS	Westminster Pharmaceuticals, LLC	04f1d1da-ce61-45b3-acf4-903cc81d16da	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560 ndc (product): 69367-414

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313291	theophylline 400 MG Extended Release Oral Tablet	PSN	04f1d1da-ce61-45b3-acf4-903cc81d16da	1
348472	theophylline 600 MG Extended Release Oral Tablet	PSN	04f1d1da-ce61-45b3-acf4-903cc81d16da	1
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	04f1d1da-ce61-45b3-acf4-903cc81d16da	1
348472	theophylline 600 MG Extended Release Oral Tablet	SCD	04f1d1da-ce61-45b3-acf4-903cc81d16da	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69367-414-01	69367041401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-414-01)	2025-11-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg	Westminster Pharmaceuticals, LLC \| MPP Pharma LLC	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	1