Theophylline Extended-Release Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-05-22
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:04:10

Label at a glance#

ProductTheophylline

Active ingredientTHEOPHYLLINE ANHYDROUS

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theophylline extended-release tablets, 300 mg

100 Tablets

NDC 70771-1782-1

Rx only

Theophylline Extended-Release Tablets 300mg

Theophylline extended-release tablets, 450 mg

100 Tablets

NDC 70771-1783-1

Rx only

Theophylline Extended-Release Tablets 450 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	1
314241	theophylline 450 MG Extended Release Oral Tablet	PSN	1
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	1
314241	theophylline 450 MG Extended Release Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
THEOPHYLLINE ANHYDROUS Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
70771-1782-1	Theophylline	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1
70771-1783-1	Theophylline	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1782	THEOPHYLLINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 1 package rows	20240528_7339f98d-b996-4e20-a7a7-315fd2a9fa4d.zip
70771-1783	THEOPHYLLINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 1 package rows	20240528_7339f98d-b996-4e20-a7a7-315fd2a9fa4d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Theophylline
THEOPHYLLINE ANHYDROUS
HYPROMELLOSE 2208 (100 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1782	70771-1782-1
70771-1783	70771-1783-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
THEOPHYLLINE ANHYDROUS	0I55128JYK	ACTIB
HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
THEOPHYLLINE ANHYDROUS	0I55128JYK	ACTIB
HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218063-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2024-05-21
A218063-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2024-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218063-001	AB
A218063-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218063-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218063-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-05-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218063-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218063-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218063-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218063-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218063-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218063-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218063-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218063-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218063-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218063-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218063-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218063-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218063-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218063-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218063-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218063-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218063-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218063-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218063-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218063-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218063-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218063-002	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218063-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218063-002	AB	1	`a50c72e98297…`

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
Theophylline	THEOPHYLLINE	Zydus Lifesciences Limited	7339f98d-b996-4e20-a7a7-315fd2a9fa4d	2024-05-22		Exact identifier ndc (package): 70771-1782-1 ndc (package): 70771-1783-1 ndc (product): 70771-1783 ndc (product): 70771-1782 ndc11 (package): 70771178201 ndc11 (package): 70771178301 spl id: 86fdabb8-c881-4695-8127-59b26998e365 spl set id: 7339f98d-b996-4e20-a7a7-315fd2a9fa4d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.