prednisone

Product NDC: 51655-541
Requested package NDC: 51655-541-21
11-digit product format: 516550541
Labeler code: 51655
Product ID: 51655-541_4e40a22f-1b1c-1847-e063-6394a90aaa00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA208412
Marketing category: ANDA
Marketing start: 2023-05-19
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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208412-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208412-005	AB	1	`a50c72e98297…`

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	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
fc4cd6f4-e01f-ad2d-e053-6294a90aebd6	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
51655-541-18	prednisone	18 in 1 BOTTLE, PLASTIC	TABLET	18	6
51655-541-20	prednisone	20 in 1 BOTTLE, PLASTIC	TABLET	20	6
51655-541-21	prednisone	21 in 1 BOTTLE, PLASTIC	TABLET	21	6
51655-541-27	prednisone	12 in 1 BOTTLE, PLASTIC	TABLET	12	6
51655-541-52	prednisone	30 in 1 BOTTLE, PLASTIC	TABLET	30	6
51655-541-53	prednisone	10 in 1 BOTTLE, PLASTIC	TABLET	10	6
51655-541-54	prednisone	15 in 1 BOTTLE, PLASTIC	TABLET	15	6
51655-541-55	prednisone	5 in 1 BOTTLE, PLASTIC	TABLET	5	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-541	PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	4	Current NDC, 8 package rows	20240725_fc4cd6f4-e01f-ad2d-e053-6294a90aebd6.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
312615	predniSONE 20 MG Oral Tablet	PSN	fc4cd6f4-e01f-ad2d-e053-6294a90aebd6	6
312615	prednisone 20 MG Oral Tablet	SCD	fc4cd6f4-e01f-ad2d-e053-6294a90aebd6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-541-21	51655054121	21 TABLET in 1 BOTTLE, PLASTIC (51655-541-21)	21 tablet	2023-12-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6