Theophylline

Product NDC: 42858-701
Requested package NDC: 42858-701-01
11-digit product format: 428580701
Labeler code: 42858
Product ID: 42858-701_f343f33f-000b-42f5-a99f-a1cf52cecbce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals
Application: ANDA040086
Marketing category: ANDA
Marketing start: 2012-02-02
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: 2023-12-31
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	42858-701	42858-701-01	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42858-701	42858-701-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A040086-001	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15
A040086-002	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040086-002	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 · 78 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	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A040086-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040086-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040086-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040086-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040086-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040086-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040086-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040086-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040086-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040086-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040086-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040086-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040086-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040086-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040086-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040086-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040086-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040086-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040086-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040086-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040086-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040086-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040086-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040086-001	AB	1	`6a51e52b5d6a…`

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
42858-701-01	2022-12-14	C162847	48780-1	e4f33bdf-a53a-d8a0-e053-dadaa90a6e4e	Theophylline (Anhydrous) Extended-Release Tablets 400 mg
42858-701-01	2022-07-29	C162847	48780-1	e4f33bdf-a53a-d8a0-e053-dadaa90a6e4e	Theophylline (Anhydrous) Extended-Release Tablets 400 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-701-01	EA - Each	42858-701	cffb907d-fbd4-4bd4-80c6-988e7faf8ccb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-701	THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	8	Legacy NDC	20230919_bba266d2-1d22-49a9-b3db-e4f06802a8a9.zip

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	def63108-2e96-446c-a7a8-a65d54de2859	4
313291	theophylline 400 MG Extended Release Oral Tablet	SCD	def63108-2e96-446c-a7a8-a65d54de2859	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-701-01	42858070101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)	2012-02-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline (Anhydrous) Extended-Release Tablets 400 mg	Rhodes Pharmaceuticals L.P. \| Fidelio Healthcare Limburg GmbH	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	9
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
Theophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4