Theophylline

Product NDC: 29033-001
Requested package NDC: 29033-001-01
11-digit product format: 290330001
Labeler code: 29033
Product ID: 29033-001_cc6d208a-826c-4aae-a78e-da1a91c60699
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA040560
Marketing category: ANDA
Marketing start: 2020-01-23
Marketing end: 0000-00-00
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 400 mg/1
Pharmacologic classes: Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29033-001	29033-001-01	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040560-002	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21
A040560-003	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040560-002	AB
A040560-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`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	A040560-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29033-001-01	2026-01-29	C162847	48780-1	49896155-bf89-586f-e063-e6dba90add90	Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-001-01	Theophylline(Anhydrous)	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-001-01	EA - Each	29033-001	370dd737-d8b9-4cec-a827-083b4c7537f4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	2
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-001	THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	6	Legacy NDC, 1 package rows	20211103_038c2b07-8028-4dc4-847c-adafe1b0e81a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline (Anhydrous)	THEOPHYLLINE	Golden State Medical Supply, Inc.	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560
Theophylline (Anhydrous)	THEOPHYLLINE ANHYDROUS	Westminster Pharmaceuticals, LLC	04f1d1da-ce61-45b3-acf4-903cc81d16da	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560

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	038c2b07-8028-4dc4-847c-adafe1b0e81a	6
348472	theophylline 600 MG Extended Release Oral Tablet	PSN	038c2b07-8028-4dc4-847c-adafe1b0e81a	6
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	038c2b07-8028-4dc4-847c-adafe1b0e81a	6
348472	theophylline 600 MG Extended Release Oral Tablet	SCD	038c2b07-8028-4dc4-847c-adafe1b0e81a	6
313291	theophylline 400 MG Extended Release Oral Tablet	PSN	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	5
348472	theophylline 600 MG Extended Release Oral Tablet	PSN	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	5
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	5
348472	theophylline 600 MG Extended Release Oral Tablet	SCD	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-001-01	29033000101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-001-01)	2020-01-23	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	Golden State Medical Supply, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	5
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg	Nostrum Laboratories, Inc.	2021-11-01	HUMAN PRESCRIPTION DRUG LABEL	6