prednisone

Product NDC: 60219-1706
11-digit product format: 602191706
Labeler code: 60219
Product ID: 60219-1706_abdf7308-9460-4e7f-a68a-2fe647e82602
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
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: 2027-12-31
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 · 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 · 64 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
2025-01-19 17:59 UTC	2025-01	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC	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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213385-001	PREDNISONE	1MG	TABLET / ORAL		2020-06-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213385-002	PREDNISONE	5MG	TABLET / ORAL		2020-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL		2020-06-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL		2020-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL		2020-06-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL		2020-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213385-001	PREDNISONE	1MG	TABLET / ORAL		2020-06-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213385-002	PREDNISONE	5MG	TABLET / ORAL		2020-06-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	2025-01	A213385-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC	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…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213385-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213385-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213385-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213385-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213385-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213385-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213385-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213385-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213385-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213385-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213385-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213385-002	AB	1	`a67488948f0b…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 60219-1706
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

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
198144	Internal RxNorm lookup
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
0740ef68-7641-432e-bd46-4710687fc9d7	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	SPL version
60219-1706-1	prednisone	100 in 1 BOTTLE, PLASTIC	TABLET	100	14
60219-1706-2	prednisone	10 in 1 BLISTER PACK	TABLET	10	14
60219-1706-3	prednisone	10 in 1 CARTON	TABLET	10	14
60219-1706-7	prednisone	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-1706-1	EA - Each	60219-1706	a60ee825-64af-4e0f-9190-306f6275ee1d	1	2021-11-09
60219-1706-7	EA - Each	60219-1706	381b20d4-18d0-42ff-8f8a-fb95d4a3bf46	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1706	PREDNISONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]	13	Current NDC, Legacy NDC, 4 package rows	20240922_0740ef68-7641-432e-bd46-4710687fc9d7.zip

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
198144	predniSONE 1 MG Oral Tablet	PSN	0740ef68-7641-432e-bd46-4710687fc9d7	14
312617	predniSONE 5 MG Oral Tablet	PSN	0740ef68-7641-432e-bd46-4710687fc9d7	14
198144	prednisone 1 MG Oral Tablet	SCD	0740ef68-7641-432e-bd46-4710687fc9d7	14
312617	prednisone 5 MG Oral Tablet	SCD	0740ef68-7641-432e-bd46-4710687fc9d7	14
312617	predniSONE 5 MG Oral Tablet	PSN	e08ba8c5-5e26-6120-e053-2995a90a1364	4
312617	prednisone 5 MG Oral Tablet	SCD	e08ba8c5-5e26-6120-e053-2995a90a1364	4
312617	predniSONE 5 MG Oral Tablet	PSN	26a52cf5-29ce-7515-e063-6394a90a9099	1
312617	predniSONE 5 MG Oral Tablet	PSN	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	1
312617	predniSONE 5 MG Oral Tablet	PSN	6f326242-786c-44b5-9317-f5fb0485d8e2	1
312617	predniSONE 5 MG Oral Tablet	PSN	80705a8a-f007-4a18-82a6-a73733d57ea2	1
312617	predniSONE 5 MG Oral Tablet	PSN	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	1
312617	prednisone 5 MG Oral Tablet	SCD	26a52cf5-29ce-7515-e063-6394a90a9099	1
312617	prednisone 5 MG Oral Tablet	SCD	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	1
312617	prednisone 5 MG Oral Tablet	SCD	6f326242-786c-44b5-9317-f5fb0485d8e2	1
312617	prednisone 5 MG Oral Tablet	SCD	80705a8a-f007-4a18-82a6-a73733d57ea2	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
60219-1706-1	60219170601	100 TABLET in 1 BOTTLE, PLASTIC (60219-1706-1)	100 tablet	2021-08-04	0000-00-00	No	No	Current
60219-1706-2	60219170602	10 in 1 BLISTER PACK						Historical
60219-1706-3	60219170603	10 BLISTER PACK in 1 CARTON (60219-1706-3) / 10 TABLET in 1 BLISTER PACK (60219-1706-2)	10 blister pack	2021-08-04	0000-00-00	No	No	Current
60219-1706-7	60219170607	1000 TABLET in 1 BOTTLE, PLASTIC (60219-1706-7)	1000 tablet	2021-08-04	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	Amneal Pharmaceuticals NY LLC	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	14
PredniSONE Tablets, USP (5 mg) Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	A-S Medication Solutions	2025-10-12	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	A-S Medication Solutions	2025-10-12	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	A-S Medication Solutions	2025-10-12	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	Preferred Pharmaceuticals Inc.	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	3
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