prednisone

Product NDC: 0615-8439
11-digit product format: 006158439
Labeler code: 0615
Product ID: 0615-8439_cdfb3f3c-f9c8-402c-933d-c2bf6600b213
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisone
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA213385
Marketing category: ANDA
Marketing start: 2021-08-04
Substance: PREDNISONE
Active strength: 5 mg/1
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 42.

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
A213385-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2020-06-16
A213385-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB		2020-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213385-001	AB
A213385-002	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 2 · 76 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
2026-08-18 06:07:40	2026-07	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213385-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312617	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
bc37cc2e-2f6a-4131-bb6a-63b6e576df21	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
0615-8439-05	prednisone	15 in 1 BLISTER PACK	TABLET	15		1
0615-8439-39	prednisone	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8439	PREDNISONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	1	Current NDC, Legacy NDC, 2 package rows	20221112_bc37cc2e-2f6a-4131-bb6a-63b6e576df21.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	0740ef68-7641-432e-bd46-4710687fc9d7	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	Northwind Health Company, LLC	e08ba8c5-5e26-6120-e053-2995a90a1364	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	80705a8a-f007-4a18-82a6-a73733d57ea2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	6f326242-786c-44b5-9317-f5fb0485d8e2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385 ndc (product): 0615-8439

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
312617	predniSONE 5 MG Oral Tablet	PSN	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	1
312617	prednisone 5 MG Oral Tablet	SCD	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8439-05	00615843905	15 TABLET in 1 BLISTER PACK (0615-8439-05)	15 tablet	2022-10-06	0000-00-00	No	No	Current
0615-8439-39	00615843939	30 TABLET in 1 BLISTER PACK (0615-8439-39)	30 tablet	2022-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2022-11-11	HUMAN PRESCRIPTION DRUG LABEL	1