Prednisolone Sodium Phosphate

Product NDC: 81646-118
11-digit product format: 816460118
Labeler code: 81646
Product ID: 81646-118_871e80dd-3a5d-4e30-bd2e-90c25c052b32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone Sodium Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: PINNACLE PHARMA LLC
Application: ANDA078988
Marketing category: ANDA
Marketing start: 2017-01-31
Marketing end: 0000-00-00
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 20 mg/5mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	81646-118		I	Inactivated by FDA		2026-08-11
excluded package	package	81646-118	81646-118-05	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81646-118-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81646-118-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81646-118-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81646-118-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81646-118-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81646-118-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81646-118-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81646-118-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81646-118-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81646-118-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81646-118-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81646-118-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	81646-118-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	81646-118-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	81646-118-05	`1332a3947898…`	`d4bfe170f9cd…`

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
A078988-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078988-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078988-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	AA	1	`cb3db0bc1861…`

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
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
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
81646-118-05	2023-01-30	C162847	48780-1	f386c649-ada6-0266-e053-dadaa90a7c1a	PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81646-118-05	Prednisolone Sodium Phosphate	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81646-118	PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PINNACLE PHARMA LLC]	1	Legacy NDC, 1 package rows	20210710_1d247de0-f2e2-43a6-8698-1b2ea6b44260.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	acc8badf-d9fd-4f99-a650-a149138b68b1	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078988 application number: ANDA078988

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IV021NXA9J	PREDNISOLONE SODIUM PHOSPHATE	125-02-0	PREDNISOLONE SODIUM PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702306	prednisoLONE sodium phosphate 20 MG in 5 mL Oral Solution	PSN	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1
702306	prednisolone 4 MG/ML Oral Solution	SCD	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1
702306	prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral Solution	SY	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81646-118-05	81646011805	5 mL in 1 CUP, UNIT-DOSE (81646-118-05)	5 ml	2017-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)	PINNACLE PHARMA LLC	2021-07-08	HUMAN PRESCRIPTION DRUG LABEL	1