Theo-24

Product NDC: 52244-200
11-digit product format: 522440200
Labeler code: 52244
Product ID: 52244-200_95d19693-50ba-43fc-81fe-6cddc537703a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: theophylline anhydrous
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: ENDO USA, Inc.
Application: ANDA087943
Marketing category: ANDA
Marketing start: 2014-08-25
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 200 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A087943-001	THEO-24	THEOPHYLLINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22
A087943-002	THEO-24	THEOPHYLLINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22
A087943-003	THEO-24	THEOPHYLLINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22
A087943-004	THEO-24	THEOPHYLLINE	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28

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 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087943-001	THEO-24	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1983-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087943-002	THEO-24	100MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087943-003	THEO-24	300MG	CAPSULE, EXTENDED RELEASE / ORAL		1983-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087943-004	THEO-24	400MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	1992-02-28	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Theo-24
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	200 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198264	Internal RxNorm lookup
313272	Internal RxNorm lookup
313310	Internal RxNorm lookup
701712	Internal RxNorm lookup
844590	Internal RxNorm lookup
844591	Internal RxNorm lookup
844813	Internal RxNorm lookup
844829	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
7a108fa0-c230-475f-be93-6f864b98a410	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
52244-200-10	Theo-24	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52244-200-10	EA - Each	52244-200	57466a2d-08ef-4ec8-b204-ecc75513ec1d	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ACTIENT PHARMACEUTICALS, LLC]	3
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ACTIENT PHARMACEUTICALS, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52244-200	THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20240709_7a108fa0-c230-475f-be93-6f864b98a410.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theo-24	THEOPHYLLINE ANHYDROUS	ENDO USA, Inc.	7a108fa0-c230-475f-be93-6f864b98a410	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087943 application number: ANDA087943 ndc (product): 52244-200

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
844590	Theo-24 100 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
844813	Theo-24 200 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
844591	Theo-24 300 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
844829	Theo-24 400 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
701712	theophylline 100 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
313272	theophylline 200 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
313310	theophylline 300 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
198264	theophylline 400 MG Extended Release Oral Capsule	PSN	7a108fa0-c230-475f-be93-6f864b98a410	11
844590	theophylline 100 MG Extended Release Oral Capsule [Theo-24]	SBD	7a108fa0-c230-475f-be93-6f864b98a410	11
844813	theophylline 200 MG Extended Release Oral Capsule [Theo-24]	SBD	7a108fa0-c230-475f-be93-6f864b98a410	11
844591	theophylline 300 MG Extended Release Oral Capsule [Theo-24]	SBD	7a108fa0-c230-475f-be93-6f864b98a410	11
844829	theophylline 400 MG Extended Release Oral Capsule [Theo-24]	SBD	7a108fa0-c230-475f-be93-6f864b98a410	11
701712	theophylline 100 MG Extended Release Oral Capsule	SCD	7a108fa0-c230-475f-be93-6f864b98a410	11
313272	theophylline 200 MG Extended Release Oral Capsule	SCD	7a108fa0-c230-475f-be93-6f864b98a410	11
313310	theophylline 300 MG Extended Release Oral Capsule	SCD	7a108fa0-c230-475f-be93-6f864b98a410	11
198264	theophylline 400 MG Extended Release Oral Capsule	SCD	7a108fa0-c230-475f-be93-6f864b98a410	11
844590	Theo-24 100 MG Extended Release Oral Capsule	SY	7a108fa0-c230-475f-be93-6f864b98a410	11
844813	Theo-24 200 MG Extended Release Oral Capsule	SY	7a108fa0-c230-475f-be93-6f864b98a410	11
844591	Theo-24 300 MG Extended Release Oral Capsule	SY	7a108fa0-c230-475f-be93-6f864b98a410	11
844829	Theo-24 400 MG Extended Release Oral Capsule	SY	7a108fa0-c230-475f-be93-6f864b98a410	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52244-200-10	52244020010	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)	2014-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theo-24 ® (theophylline anhydrous) Extended-release capsules 100, 200, 300, & 400 mg	ENDO USA, Inc. \| Neolpharma, Inc. \| Siegfried PharmaChemikalien Minden Gmbh	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	11
Lannett Company, Inc. \| SGS Life Science Services \| Eurofins Lancaster Laboratories, Inc \| NEOLPHARMA, INC. \| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) \| Siegfried PharmaChemikalien Minden Gmbh \| Aesica Pharmaceuticals GmbH \| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) \| Aspen Oss B.V. \| Mipharm SPA blanket no changes certification of product listing	Lannett Company, Inc. \| SGS Life Science Services \| Eurofins Lancaster Laboratories, Inc \| NEOLPHARMA, INC. \| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) \| Siegfried PharmaChemikalien Minden Gmbh \| Aesica Pharmaceuticals GmbH \| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) \| Aspen Oss B.V. \| Mipharm SPA	2017-10-11	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING	1