Prednisolone

Product NDC: 50383-042
11-digit product format: 503830042
Labeler code: 50383
Product ID: 50383-042_a9a3b5c0-b0e6-44b6-993d-f4e85e750b05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040401
Marketing category: ANDA
Marketing start: 2003-02-27
Marketing end: 0000-00-00
Substance: PREDNISOLONE
Active strength: 15 mg/5mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-042-24	2024-01-30	C162847	48780-1	1030e365-2ef0-111a-e063-dadaa90a10e2	PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL
50383-042-48	2024-01-30	C162847	48780-1	1030e365-2ef0-111a-e063-dadaa90a10e2	PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-042-24	ML - Milliliter	50383-042	dba79c2d-1968-4766-8464-9f0a1f840ec6	1	2012-07-24
50383-042-48	ML - Milliliter	50383-042	b5cfd5e4-2f3f-414c-99dd-b01a7f31378a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISOLONE	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SOLUTION [HI-TECH PHARMACAL CO., INC.]	4
PREDNISOLONE	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SOLUTION [DISPENSING SOLUTIONS, INC.]	3
Prednisolone	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [STAT RX USA]	1
Prednisolone	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
PREDNISOLONE	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [DIRECT RX]	1
Prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [STAT RX USA]	1
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [DIRECT RX]	1
Prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISOLONE SOLUTION [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PREDNISOLONE SOLUTION [DIRECT RX]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREDNISOLONE SOLUTION [DIRECT RX]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	PREDNISOLONE SOLUTION [DIRECT RX]	1
citric acid	INACTIVE INGREDIENT	2968PHW8QP	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SOLUTION [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREDNISOLONE SOLUTION [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREDNISOLONE SOLUTION [DIRECT RX]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE SOLUTION [DIRECT RX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISOLONE SOLUTION [DIRECT RX]	1
PRUNUS SEROTINA FRUIT	INACTIVE INGREDIENT	A77056YJ4K	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISOLONE SOLUTION [DIRECT RX]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREDNISOLONE SOLUTION [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SOLUTION [DIRECT RX]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-042	PREDNISOLONE SOLUTION [AKORN]	8	Legacy NDC	20220920_6b201232-4a52-487c-b963-a98539469e5d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9PHQ9Y1OLM	PREDNISOLONE	50-24-8	PREDNISOLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	56bd89a3-279d-46f0-bcf8-7ee595547d6b	3
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	b339a007-6a1e-6578-e053-2995a90a53d0	3
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	bc518439-dd92-438c-b650-b0b327c53a3d	3
283077	prednisolone 3 MG/ML Oral Solution	SCD	56bd89a3-279d-46f0-bcf8-7ee595547d6b	3
283077	prednisolone 3 MG/ML Oral Solution	SCD	b339a007-6a1e-6578-e053-2995a90a53d0	3
283077	prednisolone 3 MG/ML Oral Solution	SCD	bc518439-dd92-438c-b650-b0b327c53a3d	3
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	bc518439-dd92-438c-b650-b0b327c53a3d	3
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	b339a007-6a1e-6578-e053-2995a90a53d0	3
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	56bd89a3-279d-46f0-bcf8-7ee595547d6b	3
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	bc518439-dd92-438c-b650-b0b327c53a3d	3
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	56bd89a3-279d-46f0-bcf8-7ee595547d6b	3
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	b339a007-6a1e-6578-e053-2995a90a53d0	3
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	8bea1481-939d-4bea-a366-0ea435d81288	1
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	fd5a9d06-81ca-4f26-86de-4b1bda6e86be	1
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	27ff96c5-dc36-1415-e054-00144ff8d46c	1
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	cb9ea507-af03-4998-b093-765ba5b4427c	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	fd5a9d06-81ca-4f26-86de-4b1bda6e86be	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	cb9ea507-af03-4998-b093-765ba5b4427c	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	8bea1481-939d-4bea-a366-0ea435d81288	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	27ff96c5-dc36-1415-e054-00144ff8d46c	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	fd5a9d06-81ca-4f26-86de-4b1bda6e86be	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	27ff96c5-dc36-1415-e054-00144ff8d46c	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	cb9ea507-af03-4998-b093-765ba5b4427c	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	8bea1481-939d-4bea-a366-0ea435d81288	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	cb9ea507-af03-4998-b093-765ba5b4427c	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	8bea1481-939d-4bea-a366-0ea435d81288	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	fd5a9d06-81ca-4f26-86de-4b1bda6e86be	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	27ff96c5-dc36-1415-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-042-24	50383004224	1 BOTTLE in 1 CARTON (50383-042-24) > 240 mL in 1 BOTTLE	1 bottle	2003-02-27	0000-00-00	No	No	Current
50383-042-48	50383004248	1 BOTTLE in 1 CARTON (50383-042-48) > 480 mL in 1 BOTTLE	1 bottle	2003-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE ORAL SOLUTION 15 mg per 5 mL	RedPharm Drug, Inc. \| EPM Packaging, Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	3
PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL	Akorn \| Akorn Operating Company LLC	2022-09-19	HUMAN PRESCRIPTION DRUG LABEL	8
PREDNOSOLONE	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL	Aidarex Pharmaceuticals LLC	2017-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL	Apotheca Inc.	2015-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL	Dispensing Solutions, Inc.	2011-10-03	HUMAN PRESCRIPTION DRUG LABEL	3
PREDNISOLONE	Rebel Distributors Corp	2010-11-10	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE solution	Stat Rx USA	2009-10-27	HUMAN PRESCRIPTION DRUG LABEL	1

Prednisolone

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#