Theophylline

Product NDC: 69452-267
11-digit product format: 694520267
Labeler code: 69452
Product ID: 69452-267_07895277-4273-508f-e063-6394a90a40ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bionpharma Inc.,
Application: ANDA216300
Marketing category: ANDA
Marketing start: 2023-10-12
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 300 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
A216300-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-04-26
A216300-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216300-001	AB
A216300-002	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 2 · 44 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	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216300-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216300-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-04-26	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A216300-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216300-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216300-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216300-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216300-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216300-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216300-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216300-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216300-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216300-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216300-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216300-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216300-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216300-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216300-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216300-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216300-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216300-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216300-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216300-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216300-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216300-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216300-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216300-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216300-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216300-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216300-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216300-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216300-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216300-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216300-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216300-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216300-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216300-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216300-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216300-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216300-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216300-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216300-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216300-002	AB	1	`a67488948f0b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	300 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317769	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
63517422-45a0-4e78-8505-eca054068ee9	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
69452-267-20	Theophylline	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
69452-267-20	EA - Each	69452-267	574b682e-7cfc-4635-85de-ed2fc8392744	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-267	THEOPHYLLINE TABLET, EXTENDED RELEASE [BIONPHARMA INC.,]	1	Current NDC, 1 package rows	20231013_63517422-45a0-4e78-8505-eca054068ee9.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	Bionpharma Inc.,	63517422-45a0-4e78-8505-eca054068ee9	2023-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216300 application number: ANDA216300 ndc (product): 69452-267

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
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	63517422-45a0-4e78-8505-eca054068ee9	1
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	63517422-45a0-4e78-8505-eca054068ee9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-267-20	69452026720	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69452-267-20)	2023-10-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Extended-Release Tablets Rx only	Bionpharma Inc., \| Recipharm Pharmaservices Private Limited	2023-10-12	HUMAN PRESCRIPTION DRUG LABEL	1