prednisone

Product NDC: 67046-1642
Requested package NDC: 67046-1642-3
11-digit product format: 670461642
Labeler code: 67046
Product ID: 67046-1642_47bb3552-e7d2-33b5-e063-6294a90a698c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA208412
Marketing category: ANDA
Marketing start: 2026-01-06
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 · 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 · 126 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208412-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208412-005	AB	1	`5bbf6a4d5a75…`

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	5218e88b-468b-4d60-ab7e-78cca632b23a	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Cardinal Health 107, LLC	cdc2b903-5d86-45c1-b97c-2da48445dbdd	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	St. Mary's Medical Park Pharmacy	e4437eec-eadf-7c8b-e053-2a95a90af846	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Coupler LLC	53864d75-06ca-5c2a-e063-6394a90ad966	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	ecc48869-3812-4440-a398-749b28062059	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	American Health Packaging	fdcd49a6-6cb1-49f8-9f4c-feb475c129b3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Cardinal Health 107, LLC	1d797f3e-a46c-42bc-91bb-c570ae8ca8c2	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	ea4070e1-080d-4feb-9561-3910c6b712dd	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	b3b70d6f-dc44-4a54-b39b-2762f37d5575	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	QPharma Inc	11870c93-fe64-e6c9-e063-6394a90a5334	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	QPharma Inc	f795ea1d-f41a-6100-e053-6394a90a63a4	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Direct_Rx	f6051257-2144-4487-e053-2995a90a973b	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	fbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c5	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Proficient Rx LP	4b37ada5-1f22-46d5-a794-fd1477c0eb9b	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Sportpharm LLC	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	e9a74862-6a3b-4247-837a-389761b5c352	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
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	REMEDYREPACK INC.	af5d0f73-2aef-4db1-ae25-6d465c9f0ca1	2026-04-08	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

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 · 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
47bb25d2-f33c-96ce-e063-6394a90a069e	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
67046-1642-3	prednisone	30 in 1 BLISTER PACK	TABLET	30		1

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	47bb25d2-f33c-96ce-e063-6394a90a069e	1
312617	prednisone 5 MG Oral Tablet	SCD	47bb25d2-f33c-96ce-e063-6394a90a069e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1642-3	67046164203	30 TABLET in 1 BLISTER PACK (67046-1642-3)	30 tablet	2026-01-06	No	No	Current