prednisone

Product NDC: 71205-797
Requested package NDC: 71205-797-20
11-digit product format: 712050797
Labeler code: 71205
Product ID: 71205-797_0fb00b77-3fc1-4081-9540-e6a8f8e39008
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA213386
Marketing category: ANDA
Marketing start: 2020-06-24
Substance: PREDNISONE
Active strength: 20 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 43.

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
A213386-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		2020-06-24
A213386-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2020-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213386-001	AB
A213386-002	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 · 78 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	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A213386-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213386-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213386-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213386-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213386-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	20 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
312615	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
6a0c1192-8ce4-466d-a0f3-d878d67349cf	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
71205-797-10	prednisone	10 in 1 BOTTLE, PLASTIC	TABLET	10	2
71205-797-14	prednisone	14 in 1 BOTTLE, PLASTIC	TABLET	14	2
71205-797-15	prednisone	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
71205-797-20	prednisone	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
71205-797-21	prednisone	21 in 1 BOTTLE, PLASTIC	TABLET	21	2
71205-797-30	prednisone	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
71205-797-60	prednisone	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
71205-797-90	prednisone	90 in 1 BOTTLE, PLASTIC	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-797-10	EA - Each	71205-797	e489c14a-b162-4fd8-85c6-f1e5bbec6055	1	2023-08-08
71205-797-20	EA - Each	71205-797	07d4f483-467c-4b54-a0e9-683ac923884f	1	2023-08-08
71205-797-21	EA - Each	71205-797	5b518d23-7d4e-42b3-9fc7-5699cdd1fcd5	1	2023-08-08
71205-797-30	EA - Each	71205-797	de1622d2-8a63-4dd3-b955-e8f01ee6914e	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-797	PREDNISONE TABLET [PROFICIENT RX LP]	2	Current NDC, 8 package rows	20230907_6a0c1192-8ce4-466d-a0f3-d878d67349cf.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	4750028a-30ad-420a-8e6b-06dc2429d433	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	REMEDYREPACK INC.	e47a0448-331f-4846-8e63-c52c3afa274b	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Unit Dose Solutions, Inc.	5590d36d-dbe7-1c78-e063-6294a90ad2d4	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	03228706-92b9-43c9-8d73-c73aa124c58d	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Redpharm Drug	0ab0e81c-8170-6805-e063-6294a90adfc0	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	e28359cf-0c21-487a-a1a3-d1c62cef88f9	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	8f9a581c-5fef-4089-aa94-7dc81ec5b566	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	871540d3-39c3-460c-a855-3aeabfd87267	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	81cef50e-394a-49b3-8723-28df68a742d6	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	aaea2307-7893-48e9-af64-26172d08d4e8	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	7b60255f-7d0b-4f91-a75c-6682ac446f6b	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Proficient Rx LP	6a0c1192-8ce4-466d-a0f3-d878d67349cf	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (package): 71205-797-20 ndc (product): 71205-797 ndc11 (package): 71205079720
prednisone	PREDNISONE	Proficient Rx LP	6ec5b58c-65e9-47ee-b2ac-7d0b395a0630	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386

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
312615	predniSONE 20 MG Oral Tablet	PSN	6a0c1192-8ce4-466d-a0f3-d878d67349cf	2
312615	prednisone 20 MG Oral Tablet	SCD	6a0c1192-8ce4-466d-a0f3-d878d67349cf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71205-797-20	71205079720	20 TABLET in 1 BOTTLE, PLASTIC (71205-797-20)	20 tablet	2023-05-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP (20 mg) Rx only	Proficient Rx LP	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	2