Theophylline

Product NDC: 68462-356
11-digit product format: 684620356
Labeler code: 68462
Product ID: 68462-356_7c8e32e3-ca36-4ad2-971b-446c12a81992
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090355
Marketing category: ANDA
Marketing start: 2010-07-13
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 600 mg/1
Pharmacologic classes: Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A090355-001	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-07-13
A090355-002	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090355-001	AB
A090355-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090355-001	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090355-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-07-13	`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	A090355-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090355-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090355-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090355-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090355-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090355-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090355-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090355-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090355-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090355-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090355-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090355-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090355-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090355-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090355-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090355-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090355-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090355-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090355-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090355-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090355-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090355-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090355-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090355-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090355-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090355-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090355-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090355-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090355-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090355-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090355-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090355-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090355-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090355-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090355-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090355-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090355-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090355-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090355-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090355-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Theophylline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	600 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
56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	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
68462-356-01	Theophylline	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		10
68462-356-05	Theophylline	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-356-01	EA - Each	68462-356	528dbdfb-60f9-491d-89cf-342e2ab82d36	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-356	THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	9	Current NDC, Legacy NDC, 2 package rows	20240104_56fc2167-ceb6-4e3e-8ff7-5e400dfbd533.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
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090355 application number: ANDA090355 ndc (product): 68462-356

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	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	10
348472	theophylline 600 MG Extended Release Oral Tablet	PSN	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	10
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	10
348472	theophylline 600 MG Extended Release Oral Tablet	SCD	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-356-01	68462035601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-01)	2010-07-13	0000-00-00	No	No	Current
68462-356-05	68462035605	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-05)	2010-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline (Anhydrous) Extended Release Tablets 400 mg and 600 mg	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	10