Theophylline

Product NDC: 27808-033
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

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 Identifiers#

Field, Values table
Field	Values
Unii	0I55128JYK
Rxcui	313306

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	Uploaded
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

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