Theophylline

Product NDC: 27808-033
Requested package NDC: 27808-033-01
11-digit product format: 278080033
Labeler code: 27808
Product ID: 27808-033_723b1708-84c4-4a42-99bb-475c77bed2ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Theophylline
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA091586
Marketing category: ANDA
Marketing start: 2012-08-02
Substance: THEOPHYLLINE ANHYDROUS
Active strength: 80 mg/15mL
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 · 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 · 43 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	A091586-001	THEOPHYLLINE	80MG/15ML	SOLUTION / ORAL	AA	2012-06-15	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A091586-001	AA	1	`84e616aacf4f…`
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…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THEOPHYLLINE ANHYDROUS	80 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0I55128JYK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313306	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
78a99bfe-6ebe-4ace-80b0-ee019921435e	Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27808-033-01	Theophylline	473 mL in 1 BOTTLE	SOLUTION	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27808-033-01	ML - Milliliter	27808-033	5c3bf08e-e8ce-44cd-81ec-8de6e07d8fc5	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THEOPHYLLINE ANHYDROUS	ACTIVE INGREDIENT	0I55128JYK	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
THEOPHYLLINE ANHYDROUS	ACTIVE MOIETY	0I55128JYK	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THEOPHYLLINE SOLUTION [TRIS PHARMA INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-033	THEOPHYLLINE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250131_78a99bfe-6ebe-4ace-80b0-ee019921435e.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 · 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 ndc (package): 27808-033-01 ndc (product): 27808-033 ndc11 (package): 27808003301

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
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	955dba5e-c3b7-4a45-8650-e1b4722dbaea	101
313306	theophylline 5.33 MG/ML Oral Solution	SCD	955dba5e-c3b7-4a45-8650-e1b4722dbaea	101
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	955dba5e-c3b7-4a45-8650-e1b4722dbaea	101
313306	theophylline 80 MG per 15 ML Oral Solution	SY	955dba5e-c3b7-4a45-8650-e1b4722dbaea	101
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	100
313306	theophylline 5.33 MG/ML Oral Solution	SCD	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	100
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	100
313306	theophylline 80 MG per 15 ML Oral Solution	SY	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	100
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	78a99bfe-6ebe-4ace-80b0-ee019921435e	6
313306	theophylline 5.33 MG/ML Oral Solution	SCD	78a99bfe-6ebe-4ace-80b0-ee019921435e	6
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	78a99bfe-6ebe-4ace-80b0-ee019921435e	6
313306	theophylline 80 MG per 15 ML Oral Solution	SY	78a99bfe-6ebe-4ace-80b0-ee019921435e	6
313306	theophylline 80 MG in 15 mL Oral Solution	PSN	47e484c2-f59e-4a71-bb97-c90f128ac345	5
313306	theophylline 5.33 MG/ML Oral Solution	SCD	47e484c2-f59e-4a71-bb97-c90f128ac345	5
313306	theophylline 100 MG per 18.75 ML Oral Solution	SY	47e484c2-f59e-4a71-bb97-c90f128ac345	5
313306	theophylline 80 MG per 15 ML Oral Solution	SY	47e484c2-f59e-4a71-bb97-c90f128ac345	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-033-01	27808003301	473 mL in 1 BOTTLE (27808-033-01)	473 ml	2012-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theophylline Oral Solution, USP 80 mg/15 mL Rx Only	ATLANTIC BIOLOGICALS CORP.	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	5
Theophylline Oral Solution, USP 80 mg/15 mL Rx Only	Bryant Ranch Prepack	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	100
Theophylline Oral Solution, USP 80 mg/15 mL Rx Only	Bryant Ranch Prepack	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	101
Theophylline Oral Solution, USP 80 mg/15 mL Rx Only	Cranbury Pharmaceuticals, LLC	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	6