PREDNISONE

Product NDC: 68071-2661
11-digit product format: 680712661
Labeler code: 68071
Product ID: 68071-2661_16c598f5-b678-c5ae-e063-6294a90aa28c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA208412
Marketing category: ANDA
Marketing start: 2021-09-01
Substance: PREDNISONE
Active strength: 10 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 44.

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
A208412-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11
A208412-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11
A208412-003	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11
A208412-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20
A208412-005	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208412-001	AB
A208412-002	AB
A208412-003	AB
A208412-004	AB
A208412-005	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 4 · 141 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
2026-10-15 13:18:30	2026-09	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208412-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208412-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208412-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	AB	1	`b8a1b40f171c…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	10 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
198145	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
db4a13ff-546d-15b7-e053-2a95a90a6adf	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
68071-2661-0	PREDNISONE	10 in 1 BOTTLE, PLASTIC	TABLET	10	2
68071-2661-1	PREDNISONE	21 in 1 BOTTLE, PLASTIC	TABLET	21	2
68071-2661-2	PREDNISONE	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
68071-2661-3	PREDNISONE	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
68071-2661-5	PREDNISONE	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
68071-2661-6	PREDNISONE	6 in 1 BOTTLE, PLASTIC	TABLET	6	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2661	PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 6 package rows	20240425_db4a13ff-546d-15b7-e053-2a95a90a6adf.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	b540f4af-8f07-4c56-b151-d759440c514a	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	70d05ed7-5c4e-4cd1-84cd-0dbe90692c54	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Asclemed USA, Inc.	fdcf3271-fae7-47ef-a370-adbdc0a3cf37	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Sportpharm LLC	0e3d2f62-2b02-4ddf-a983-abb71ff31e36	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Coupler LLC	47bb25d2-f33c-96ce-e063-6394a90a069e	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Northwind Health Company, LLC	f2f1a2ea-fa1b-b4f1-e053-2995a90aa276	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Northwind Health Company, LLC	f7e523ab-d831-6acf-e053-6294a90a79a3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Northwind Health Company, LLC	fc4cd6f4-e01f-ad2d-e053-6294a90aebd6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Strides Pharma Science Limited	2ef05381-faad-4e0f-b58d-9f2236a04a2c	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Strides Pharma Science Limited	52010a34-aadb-4561-ac4a-3ee53f5e3566	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Direct_Rx	24882e23-c05f-f2ee-e063-6294a90a536f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Coupler LLC	3e0e3e28-e6ff-7b48-e063-6294a90a9acd	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	2d0562ad-6175-833c-e063-6394a90ad029	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Proficient Rx LP	c2f477da-0b99-4fc4-89ca-94831de950a3	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	9a2d3bee-610b-44dc-8266-869aaf08f0d1	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	f0354431-4968-4e34-969b-6985d73700a4	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	A-S Medication Solutions	1cb252f0-fd01-4620-bf88-2108fc1ea615	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Direct_Rx	fd8eb82e-52df-c368-e053-6294a90ac6b0	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	A-S Medication Solutions	90b8b43e-01f9-4503-91c4-2b3cbae91a83	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	A-S Medication Solutions	f4cc64f8-781f-437a-a4a7-2d163026d1c2	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412

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
198145	predniSONE 10 MG Oral Tablet	PSN	db4a13ff-546d-15b7-e053-2a95a90a6adf	2
198145	prednisone 10 MG Oral Tablet	SCD	db4a13ff-546d-15b7-e053-2a95a90a6adf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2661-0	68071266100	10 TABLET in 1 BOTTLE, PLASTIC (68071-2661-0)	10 tablet	2022-03-28	0000-00-00	No	No	Current
68071-2661-1	68071266101	21 TABLET in 1 BOTTLE, PLASTIC (68071-2661-1)	21 tablet	2022-03-28	0000-00-00	No	No	Current
68071-2661-2	68071266102	20 TABLET in 1 BOTTLE, PLASTIC (68071-2661-2)	20 tablet	2022-03-28	0000-00-00	No	No	Current
68071-2661-3	68071266103	30 TABLET in 1 BOTTLE, PLASTIC (68071-2661-3)	30 tablet	2022-03-28	0000-00-00	No	No	Current
68071-2661-5	68071266105	15 TABLET in 1 BOTTLE, PLASTIC (68071-2661-5)	15 tablet	2022-03-28	0000-00-00	No	No	Current
68071-2661-6	68071266106	6 TABLET in 1 BOTTLE, PLASTIC (68071-2661-6)	6 tablet	2022-03-28		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets USP Rx only	NuCare Pharmaceuticals,Inc.	2024-04-23	HUMAN PRESCRIPTION DRUG LABEL	2