Theophylline

Product NDC: 71321-501
11-digit product format: 713210501
Labeler code: 71321
Product ID: 71321-501_9c1ede62-fd47-41f4-96da-93d65133042d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Brandywine Pharmaceuticals, LLC
Application: ANDA087400
Marketing category: ANDA
Marketing start: 2025-09-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71321-501		I	Inactivated by FDA		2026-08-07
excluded package	package	71321-501	71321-501-10	I	Inactivated by FDA		2026-08-07

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	TE codes	Approval date
A087400-002	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11
A087400-003	THEOPHYLLINE	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21
A087400-004	THEOPHYLLINE	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21
A087400-005	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087400-002	AB
A087400-005	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 4 · 143 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	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A087400-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087400-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087400-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087400-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087400-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087400-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087400-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087400-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087400-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087400-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087400-005	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A087400-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087400-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087400-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087400-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087400-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087400-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087400-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087400-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087400-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087400-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087400-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087400-004	AB	1	`3f01610625f2…`

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
71321-501-10	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
71321-501-10	EA - Each	71321-501	2febf827-41f0-4fcb-b5e3-6b93da921b89	1	2025-12-16

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
237178	theophylline 100 MG Extended Release Oral Tablet	PSN	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1
346574	theophylline 200 MG Extended Release Oral Tablet	PSN	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1
237178	theophylline 100 MG Extended Release Oral Tablet	SCD	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1
346574	theophylline 200 MG Extended Release Oral Tablet	SCD	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	7b98b47d-0a6e-4621-b047-bdb8bcef4836	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71321-501-10	71321050110	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-501-10)	2025-09-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Extended-Release Tablets Rx only	Brandywine Pharmaceuticals, LLC \| Brandywine Pharmaceuticals LLC \| Nostrum Laboratories, Inc. \| Unit Dose Solutions, Inc.	2025-09-19	Human Prescription Drug Label	1