ELIXOPHYLLIN

Product NDC: 70408-644
11-digit product format: 704080644
Labeler code: 70408
Product ID: 70408-644_50870177-6eff-41c1-85a4-670836703a30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: THEOPHYLLINE ANHYDROUS
Dosage form: LIQUID
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA085186
Marketing category: ANDA
Marketing start: 2009-10-01
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	70408-644		I	Inactivated by FDA		2026-08-07
excluded package	package	70408-644	70408-644-34	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A085186-001	ELIXOPHYLLIN	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR / ORAL		RLD, Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085186-001	ELIXOPHYLLIN	80MG/15ML	SOLUTION, ELIXIR / ORAL	AA	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085186-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085186-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085186-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085186-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085186-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085186-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085186-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085186-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085186-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085186-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085186-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085186-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085186-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085186-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085186-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085186-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085186-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085186-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085186-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085186-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085186-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085186-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085186-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085186-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085186-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085186-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085186-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085186-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085186-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085186-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085186-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085186-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085186-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085186-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085186-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085186-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085186-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085186-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085186-001	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
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2	Product name	1	20170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70408-644-34	ELIXOPHYLLIN	473 mL in 1 BOTTLE	LIQUID	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70408-644-34	ML - Milliliter	70408-644	e004792f-2ad4-4861-a2a5-65b6c5f32790	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70408-644	ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [NOSTRUM LABORATORIES, INC.]	2	Legacy NDC, 1 package rows	20181214_b488f996-2f80-438a-8333-b837f9acd4fc.zip

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
756226	Elixophyllin 80 MG in 15 mL Elixir	PSN	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
756226	theophylline 5.33 MG/ML Oral Solution [Elixophyllin]	SBD	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
313306	theophylline 5.33 MG/ML Oral Solution	SCD	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
756226	Elixophyllin 100 MG per 18.75 ML Elixir	SY	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
756226	Elixophyllin 5.33 MG/ML Oral Solution	SY	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
756226	Elixophyllin 80 MG per 15 ML Elixir	SY	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
313306	theophylline 80 MG per 15 ML Oral Solution	SY	8328cefd-49aa-4621-a7c3-49a14a19cbe7	4
756226	Elixophyllin 80 MG in 15 mL Elixir	PSN	b488f996-2f80-438a-8333-b837f9acd4fc	2
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	b488f996-2f80-438a-8333-b837f9acd4fc	2
756226	theophylline 5.33 MG/ML Oral Solution [Elixophyllin]	SBD	b488f996-2f80-438a-8333-b837f9acd4fc	2
313306	theophylline 5.33 MG/ML Oral Solution	SCD	b488f996-2f80-438a-8333-b837f9acd4fc	2
756226	Elixophyllin 100 MG per 18.75 ML Elixir	SY	b488f996-2f80-438a-8333-b837f9acd4fc	2
756226	Elixophyllin 5.33 MG/ML Oral Solution	SY	b488f996-2f80-438a-8333-b837f9acd4fc	2
756226	Elixophyllin 80 MG per 15 ML Elixir	SY	b488f996-2f80-438a-8333-b837f9acd4fc	2
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	b488f996-2f80-438a-8333-b837f9acd4fc	2
313306	theophylline 80 MG per 15 ML Oral Solution	SY	b488f996-2f80-438a-8333-b837f9acd4fc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70408-644-34	70408064434	473 mL in 1 BOTTLE (70408-644-34)	473 ml	2009-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) (brand of theophylline anhydrous) Rx Only	Nostrum Laboratories, Inc.	2018-12-13	Human Prescription Drug Label	2
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) (brand of theophylline anhydrous) Rx Only	Carilion Materials Management	2018-02-06	Human Prescription Drug Label	4