Theophylline

Product NDC: 60621-033
11-digit product format: 606210033
Labeler code: 60621
Product ID: 60621-033_dc890dd5-ab65-4d2f-816d-ecd23ea77734
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline Anhydrous
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals Inc
Application: ANDA091586
Marketing category: ANDA
Marketing start: 2014-11-03
Marketing end: 0000-00-00
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 80 mg/15mL
Pharmacologic classes: Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60621-033		D	Discontinued by firm		2026-08-17
excluded package	package	60621-033	60621-033-01	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60621-033-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60621-033-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60621-033-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60621-033-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60621-033-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60621-033-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60621-033-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60621-033-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60621-033-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60621-033-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60621-033-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60621-033-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091586-001	THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA		2012-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091586-001	AA

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 · 42 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
2026-08-18 06:07:40	2026-07	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091586-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091586-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091586-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091586-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091586-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091586-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091586-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091586-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091586-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091586-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091586-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091586-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091586-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091586-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091586-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091586-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091586-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091586-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091586-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091586-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091586-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091586-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091586-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091586-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091586-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091586-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091586-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091586-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091586-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091586-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091586-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091586-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091586-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091586-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091586-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091586-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091586-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091586-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091586-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091586-001	AA	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [CRANBURY PHARMACEUTICALS INC]	4

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	ATLANTIC BIOLOGICALS CORP.	47e484c2-f59e-4a71-bb97-c90f128ac345	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091586 application number: ANDA091586
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091586 application number: ANDA091586
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	955dba5e-c3b7-4a45-8650-e1b4722dbaea	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091586 application number: ANDA091586
Theophylline	THEOPHYLLINE	Cranbury Pharmaceuticals, LLC	78a99bfe-6ebe-4ace-80b0-ee019921435e	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091586 application number: ANDA091586

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0I55128JYK	THEOPHYLLINE ANHYDROUS	58-55-9	THEOPHYLLINE ANHYDROUS

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Oral Solution	Cranbury Pharmaceuticals Inc \| Tris Pharma, Inc.	2014-11-19	HUMAN PRESCRIPTION DRUG LABEL	4