Prednisone

Product NDC: 70518-3142
11-digit product format: 705183142
Labeler code: 70518
Product ID: 70518-3142_d2cc6d86-7c06-5ec1-e053-2995a90ae079
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA211575
Marketing category: ANDA
Marketing start: 2021-07-05
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 5 mg/1
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-3142		D	Discontinued by firm	2026-10-05
excluded package	package	70518-3142	70518-3142-0	D	Discontinued by firm	2026-10-05
excluded package	package	70518-3142	70518-3142-1	D	Discontinued by firm	2026-10-05
excluded package	package	70518-3142	70518-3142-2	D	Discontinued by firm	2026-10-05

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 · 25 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	70518-3142-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3142-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3142-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3142-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3142-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3142-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3142-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3142-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3142-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3142-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3142-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3142-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3142-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3142-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3142-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3142-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3142-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3142-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3142-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3142-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3142-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3142-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3142-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3142-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211575-001	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15
A211575-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15
A211575-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15
A211575-004	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15
A211575-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A211575-001	AB
A211575-002	AB
A211575-003	AB
A211575-004	AB
A211575-005	AB

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 5 · 200 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	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 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	A211575-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-3142-0	2023-03-17	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
70518-3142-1	2023-03-17	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
70518-3142-2	2023-03-17	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
70518-3142-0	2023-01-30	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
70518-3142-1	2023-01-30	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
70518-3142-2	2023-01-30	PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3142	PREDNISONE TABLET [REMEDYREPACK INC.]	8	Legacy NDC	20240926_9e2bd1de-e759-46e0-a12f-734660e8e8bf.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Proficient Rx LP	35f504c3-1cf5-455d-8226-9ffeea606623	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VB0R961HZT	PREDNISONE	53-03-2	PREDNISONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3142-0	70518314200	30 TABLET in 1 BLISTER PACK (70518-3142-0)	30 tablet	2021-07-05	0000-00-00	No	No	Current
70518-3142-1	70518314201	180 TABLET in 1 BOTTLE, PLASTIC (70518-3142-1)	180 tablet	2021-09-24	0000-00-00	No	No	Current
70518-3142-2	70518314202	180 TABLET in 1 BOTTLE, PLASTIC (70518-3142-2)	180 tablet	2021-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only	REMEDYREPACK INC.	2025-07-17	HUMAN PRESCRIPTION DRUG LABEL	9