Theophylline

Product NDC: 10135-604
11-digit product format: 101350604
Labeler code: 10135
Product ID: 10135-604_d21b83e5-364a-44c4-ae8c-a371ff5aeb22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline Anhydrous
Dosage form: SOLUTION
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA091156
Marketing category: ANDA
Marketing start: 2016-02-01
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: 2020-12-31
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	10135-604		I	Inactivated by FDA		2026-08-07
excluded package	package	10135-604	10135-604-08	I	Inactivated by FDA		2026-08-07

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 · 38 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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`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	10135-604-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-604-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-604-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-604-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-604-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-604-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-604-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-604-08	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091156-001	THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091156-001	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 · 41 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	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091156-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	RS	2011-04-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A091156-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091156-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091156-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091156-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091156-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091156-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091156-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091156-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091156-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091156-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091156-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091156-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091156-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091156-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091156-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091156-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091156-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091156-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091156-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091156-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091156-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091156-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091156-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091156-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091156-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091156-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091156-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091156-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091156-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091156-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091156-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091156-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091156-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091156-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091156-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091156-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091156-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091156-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091156-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091156-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1d07c79-5983-427d-b6f5-df0550dcc598	Product name	4	20250325
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2	Product name	1	20170302
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-604-08	2021-01-29	C162847	48780-1	ba0f9c33-2a25-a910-e053-dadaa90a0b85	Theophylline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-604-08	Theophylline	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-604-08	ML - Milliliter	10135-604	189ac122-4323-4f41-bdea-80582a40dfbe	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-604	THEOPHYLLINE (THEOPHYLLINE ANHYDROUS) SOLUTION [MARLEX PHARMACEUTICALS INC]	2	Legacy NDC, 1 package rows	20191112_02fcc06e-2a81-404f-a7cd-313fcb0d833c.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	THEOPHYLLINE	Chartwell RX, LLC	1b685384-5d96-46fa-b93b-e96538a2cfe7	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091156 application number: ANDA091156
Theophylline	THEOPHYLLINE	Chartwell Governmental & Specialty RX, LLC.	e2716dac-8b23-4e06-bc3e-4dd76b7c813e	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091156 application number: ANDA091156

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	02fcc06e-2a81-404f-a7cd-313fcb0d833c	2
313306	theophylline 5.33 MG/ML Oral Solution	SCD	02fcc06e-2a81-404f-a7cd-313fcb0d833c	2
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	02fcc06e-2a81-404f-a7cd-313fcb0d833c	2
313306	theophylline 80 MG per 15 ML Oral Solution	SY	02fcc06e-2a81-404f-a7cd-313fcb0d833c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
10135-604-08	10135060408	473 mL in 1 BOTTLE, PLASTIC	473 ml	Historical