Prednisone

Product NDC: 70518-0305
Requested package NDC: 70518-0305-0
11-digit product format: 705180305
Labeler code: 70518
Product ID: 70518-0305_47e6e598-f47b-d0fc-e063-6394a90a1a81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040256
Marketing category: ANDA
Marketing start: 2017-03-10
Substance: PREDNISONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040256-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB		2002-07-12
A040256-002	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		2002-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040256-001	AB
A040256-002	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 3 · 82 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	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040256-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040256-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040256-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040256-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040256-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040256-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040256-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040256-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040256-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040256-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VB0R961HZT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312617	Internal RxNorm lookup
763181	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
746b0bcd-122e-4ea8-a824-28415073a38e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2205d503-be51-445b-bb34-c209cc557b3c	Product name	5	20230105
9492a99d-61c8-491f-9086-1c6a7e98c040	Product name	6	20230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81	Product name	2	20170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-0305-0	Prednisone	21 in 1 BOX, UNIT-DOSE	TABLET	21		13

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Bryant Ranch Prepack	931171e2-0bdb-451e-b737-72ce3ffbed53	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	55aedced-d945-4bd2-9aa8-0f18b89a0e7f	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	dc3bbb97-6588-46f4-b0ad-47596874ad0c	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	290a91e5-22ae-4d62-ab34-39a3117002e2	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	REMEDYREPACK INC.	746b0bcd-122e-4ea8-a824-28415073a38e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256 ndc (package): 70518-0305-0 ndc (product): 70518-0305 ndc11 (package): 70518030500
Prednisone	PREDNISONE	Major Pharmaceuticals	57b98930-92ab-4b77-a033-ae9895ee718a	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	71295010-5adb-499b-a03a-5c78b5e79b2d	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	efe0c82b-9dd9-4729-b06f-06307867aca0	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Cardinal Health 107, LLC	568b8880-7997-4786-8c57-28816ce52655	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Preferred Pharmaceuticals, Inc.	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	95cf05e5-1446-43f5-8447-c04877a74781	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	410988ea-456a-454e-932c-fcbdbef04ba9	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Proficient Rx LP	7d52bf53-76e3-4826-a12b-b16a8560bafc	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Aphena Pharma Solutions - Tennessee, LLC	b902ed21-c776-4046-8fbc-9ce95b16b139	2017-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	746b0bcd-122e-4ea8-a824-28415073a38e	13
312617	predniSONE 5 MG Oral Tablet	PSN	746b0bcd-122e-4ea8-a824-28415073a38e	13
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	746b0bcd-122e-4ea8-a824-28415073a38e	13
312617	prednisone 5 MG Oral Tablet	SCD	746b0bcd-122e-4ea8-a824-28415073a38e	13
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	746b0bcd-122e-4ea8-a824-28415073a38e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0305-0	70518030500	21 TABLET in 1 BOX, UNIT-DOSE (70518-0305-0)	21 tablet	2017-03-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	REMEDYREPACK INC.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	14