Prednisolone

Product NDC: 0121-0885
11-digit product format: 001210885
Labeler code: 0121
Product ID: 0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA040571
Marketing category: ANDA
Marketing start: 2023-09-12
Substance: PREDNISOLONE
Active strength: 15 mg/5mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 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
A040571-001	PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA		2005-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040571-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040571-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2005-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040571-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2005-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040571-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2005-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2005-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040571-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL		2005-08-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040571-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040571-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040571-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040571-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040571-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040571-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040571-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040571-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040571-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040571-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040571-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040571-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040571-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040571-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040571-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040571-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040571-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040571-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040571-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040571-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisolone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9PHQ9Y1OLM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283077	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
cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-0885-08	Prednisolone	240 mL in 1 BOTTLE	SOLUTION	240		2
0121-0885-16	Prednisolone	480 mL in 1 BOTTLE	SOLUTION	480		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0885-08	ML - Milliliter	0121-0885	aaf908c1-43c6-44fe-b616-caefdb058d18	1	2023-10-16
0121-0885-16	ML - Milliliter	0121-0885	186fd5dd-542c-4459-b238-3111f7d3e9e3	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0885	PREDNISOLONE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	2	Current NDC, 2 package rows	20240820_cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3.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
Prednisolone	PREDNISOLONE	A-S Medication Solutions	35f0b197-c3ae-445a-8da7-9ffcd4472e05	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040571 application number: ANDA040571
Prednisolone	PREDNISOLONE	PAI Holdings, LLC dba PAI Pharma	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040571 application number: ANDA040571 ndc (product): 0121-0885

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	35f0b197-c3ae-445a-8da7-9ffcd4472e05	4
283077	prednisolone 3 MG/ML Oral Solution	SCD	35f0b197-c3ae-445a-8da7-9ffcd4472e05	4
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	35f0b197-c3ae-445a-8da7-9ffcd4472e05	4
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	35f0b197-c3ae-445a-8da7-9ffcd4472e05	4
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2
283077	prednisolone 3 MG/ML Oral Solution	SCD	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-0885-08	00121088508	240 mL in 1 BOTTLE (0121-0885-08)	240 ml	2023-09-12	No	No	Current
0121-0885-16	00121088516	480 mL in 1 BOTTLE (0121-0885-16)	480 ml	2023-09-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PrednisoLONE Oral Solution USP 15 mg/5 mL Rx Only	A-S Medication Solutions	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	4
PrednisoLONE Oral Solution USP 15 mg/5 mL Rx Only	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	2