theophylline

Product NDC: 60219-2045
11-digit product format: 602192045
Labeler code: 60219
Product ID: 60219-2045_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: theophylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA216276
Marketing category: ANDA
Marketing start: 2023-03-27
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 43.

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
A216276-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-03-20
A216276-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216276-001	AB
A216276-002	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 · 50 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
2026-09-14 22:38:34	2026-08	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216276-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216276-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-03-20	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216276-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216276-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216276-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216276-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216276-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216276-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216276-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216276-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216276-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216276-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216276-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216276-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216276-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216276-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216276-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216276-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216276-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216276-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216276-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216276-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216276-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216276-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216276-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216276-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216276-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216276-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216276-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216276-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216276-002	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	300 mg/1

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	SPL version
60219-2045-1	theophylline	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100	3
60219-2045-3	theophylline	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	3
60219-2045-5	theophylline	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500	3
60219-2045-7	theophylline	1000 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	1000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-2045-1	EA - Each	60219-2045	92202778-7773-4229-9d96-ce19dc03e1ed	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-2045	THEOPHYLLINE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]	3	Current NDC, 4 package rows	20230327_b0d5d1cd-c79b-4229-929c-2eb3e4f43298.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
317769	theophylline 300 MG Extended Release Oral Tablet	PSN	b0d5d1cd-c79b-4229-929c-2eb3e4f43298	3
314241	theophylline 450 MG Extended Release Oral Tablet	PSN	b0d5d1cd-c79b-4229-929c-2eb3e4f43298	3
317769	theophylline 300 MG Extended Release Oral Tablet	SCD	b0d5d1cd-c79b-4229-929c-2eb3e4f43298	3
314241	theophylline 450 MG Extended Release Oral Tablet	SCD	b0d5d1cd-c79b-4229-929c-2eb3e4f43298	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60219-2045-1	60219204501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-1)	2023-03-27	No	No	Current
60219-2045-3	60219204503	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3)	2023-03-27	No	No	Current
60219-2045-5	60219204505	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-5)	2023-03-27	No	No	Current
60219-2045-7	60219204507	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-7)	2023-03-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Extended-Release Tablets Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2026-08-08	HUMAN PRESCRIPTION DRUG LABEL	5