Prednisone

Product NDC: 0603-5338
11-digit product format: 006035338
Labeler code: 0603
Product ID: 0603-5338_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA040256
Marketing category: ANDA
Marketing start: 2002-07-12
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	VB0R961HZT
Rxcui	198144, 198145, 198146, 312615, 312617, 763179, 763181, 763183, 763185

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0603-5338-15	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-15	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-21	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-21	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-28	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-28	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-31	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-31	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-32	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-32	2022-08-19	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-15	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-15	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-21	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-21	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-28	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-28	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-31	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-31	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-32	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5338-32	2022-07-29	C162847	48780-1	e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0603-5338-15	Prednisone	21 in 1 BOX, UNIT-DOSE	TABLET	21	32
0603-5338-21	Prednisone	100 in 1 BOTTLE, PLASTIC	TABLET	100	32
0603-5338-28	Prednisone	500 in 1 BOTTLE, PLASTIC	TABLET	500	32
0603-5338-31	Prednisone	48 in 1 BOX, UNIT-DOSE	TABLET	48	32
0603-5338-32	Prednisone	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-5338-15	EA - Each	0603-5338	54a140ce-96bf-43c2-b688-89c61a757f36	1	2012-07-24
0603-5338-21	EA - Each	0603-5338	eb46d86d-cad1-4757-86ff-3c42bb8be6da	1	2012-07-24
0603-5338-28	EA - Each	0603-5338	461125cc-e580-4f69-a417-e98ff9167804	1	2012-07-24
0603-5338-31	EA - Each	0603-5338	31c3d6f2-25d5-4579-a559-6605a1828d66	1	2012-07-24
0603-5338-32	EA - Each	0603-5338	b9350303-6489-457f-9a8c-b831fec71129	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]	12
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PROFICIENT RX LP]	4
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PROFICIENT RX LP]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PROFICIENT RX LP]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PROFICIENT RX LP]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PROFICIENT RX LP]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PROFICIENT RX LP]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PROFICIENT RX LP]	4
prednisone	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
prednisone	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [REDPHARM DRUG INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-5338	PREDNISONE TABLET [ENDO USA, INC.]	32	Current NDC, Legacy NDC, 5 package rows	20240927_10fe5a3b-84dc-4600-87c2-b80c97ce18cf.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
198145	predniSONE 10 MG Oral Tablet	PSN	55aedced-d945-4bd2-9aa8-0f18b89a0e7f	103
198145	prednisone 10 MG Oral Tablet	SCD	55aedced-d945-4bd2-9aa8-0f18b89a0e7f	103
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763183	{48 (prednisone 10 MG Oral Tablet) } Pack	GPCK	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763179	{48 (prednisone 5 MG Oral Tablet) } Pack	GPCK	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198144	predniSONE 1 MG Oral Tablet	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198145	predniSONE 10 MG Oral Tablet	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198145	predniSONE 10 MG Oral Tablet	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763183	predniSONE 10 MG Tablet 12 Day 48 Count Pack	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198146	predniSONE 2.5 MG Oral Tablet	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
312615	predniSONE 20 MG Oral Tablet	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
312615	predniSONE 20 MG Oral Tablet	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
312617	predniSONE 5 MG Oral Tablet	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763179	predniSONE 5 MG Tablet 12 Day 48 Count Pack	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198144	prednisone 1 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198145	prednisone 10 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198145	prednisone 10 MG Oral Tablet	SCD	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
198146	prednisone 2.5 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
312615	prednisone 20 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
312615	prednisone 20 MG Oral Tablet	SCD	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
312617	prednisone 5 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763185	Prednisone 10 MG Oral Tablet 21 Count Pack	SY	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763185	Prednisone 10 MG Oral Tablet 21 Count Pack	SY	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763183	Prednisone 10 MG Oral Tablet 48 Count Pack	SY	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
763179	Prednisone 5 MG Oral Tablet 48 Count Pack	SY	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	32
198145	predniSONE 10 MG Oral Tablet	PSN	95cf05e5-1446-43f5-8447-c04877a74781	28
198145	prednisone 10 MG Oral Tablet	SCD	95cf05e5-1446-43f5-8447-c04877a74781	28
198145	predniSONE 10 MG Oral Tablet	PSN	5e802202-77dd-4d47-abe9-3cb668fa630d	21
312615	predniSONE 20 MG Oral Tablet	PSN	5e802202-77dd-4d47-abe9-3cb668fa630d	21
312617	predniSONE 5 MG Oral Tablet	PSN	5e802202-77dd-4d47-abe9-3cb668fa630d	21
198145	prednisone 10 MG Oral Tablet	SCD	5e802202-77dd-4d47-abe9-3cb668fa630d	21
312615	prednisone 20 MG Oral Tablet	SCD	5e802202-77dd-4d47-abe9-3cb668fa630d	21
312617	prednisone 5 MG Oral Tablet	SCD	5e802202-77dd-4d47-abe9-3cb668fa630d	21
763183	{48 (prednisone 10 MG Oral Tablet) } Pack	GPCK	efe0c82b-9dd9-4729-b06f-06307867aca0	18
198145	predniSONE 10 MG Oral Tablet	PSN	efe0c82b-9dd9-4729-b06f-06307867aca0	18
763183	predniSONE 10 MG Tablet 12 Day 48 Count Pack	PSN	efe0c82b-9dd9-4729-b06f-06307867aca0	18
198146	predniSONE 2.5 MG Oral Tablet	PSN	efe0c82b-9dd9-4729-b06f-06307867aca0	18
312615	predniSONE 20 MG Oral Tablet	PSN	efe0c82b-9dd9-4729-b06f-06307867aca0	18
312617	predniSONE 5 MG Oral Tablet	PSN	efe0c82b-9dd9-4729-b06f-06307867aca0	18
198145	prednisone 10 MG Oral Tablet	SCD	efe0c82b-9dd9-4729-b06f-06307867aca0	18
198146	prednisone 2.5 MG Oral Tablet	SCD	efe0c82b-9dd9-4729-b06f-06307867aca0	18
312615	prednisone 20 MG Oral Tablet	SCD	efe0c82b-9dd9-4729-b06f-06307867aca0	18
312617	prednisone 5 MG Oral Tablet	SCD	efe0c82b-9dd9-4729-b06f-06307867aca0	18
763183	Prednisone 10 MG Oral Tablet 48 Count Pack	SY	efe0c82b-9dd9-4729-b06f-06307867aca0	18
198145	predniSONE 10 MG Oral Tablet	PSN	9242930b-6657-4951-9c79-002649654e0c	11
198145	prednisone 10 MG Oral Tablet	SCD	9242930b-6657-4951-9c79-002649654e0c	11
198145	predniSONE 10 MG Oral Tablet	PSN	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
312615	predniSONE 20 MG Oral Tablet	PSN	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
312617	predniSONE 5 MG Oral Tablet	PSN	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
198145	prednisone 10 MG Oral Tablet	SCD	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
312615	prednisone 20 MG Oral Tablet	SCD	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
312617	prednisone 5 MG Oral Tablet	SCD	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	10
198145	predniSONE 10 MG Oral Tablet	PSN	7d52bf53-76e3-4826-a12b-b16a8560bafc	9
312617	predniSONE 5 MG Oral Tablet	PSN	7d52bf53-76e3-4826-a12b-b16a8560bafc	9
198145	prednisone 10 MG Oral Tablet	SCD	7d52bf53-76e3-4826-a12b-b16a8560bafc	9
312617	prednisone 5 MG Oral Tablet	SCD	7d52bf53-76e3-4826-a12b-b16a8560bafc	9
198145	predniSONE 10 MG Oral Tablet	PSN	57b98930-92ab-4b77-a033-ae9895ee718a	7
198145	prednisone 10 MG Oral Tablet	SCD	57b98930-92ab-4b77-a033-ae9895ee718a	7
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	b8bb74be-9a37-44ec-a7cd-58f2cf99ac75	2
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
763183	{48 (prednisone 10 MG Oral Tablet) } Pack	GPCK	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
198145	predniSONE 10 MG Oral Tablet	PSN	b8bb74be-9a37-44ec-a7cd-58f2cf99ac75	2
198145	predniSONE 10 MG Oral Tablet	PSN	c960d736-2657-4b79-967f-d2c9bb4076cd	2
198145	predniSONE 10 MG Oral Tablet	PSN	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
198145	predniSONE 10 MG Oral Tablet	PSN	3d2eb1e3-fc2b-4820-abc6-cae1228df4c2	2
198145	predniSONE 10 MG Oral Tablet	PSN	1f908a83-f50e-2f19-e054-00144ff88e88	2
763183	predniSONE 10 MG Tablet 12 Day 48 Count Pack	PSN	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	b8bb74be-9a37-44ec-a7cd-58f2cf99ac75	2
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
312615	predniSONE 20 MG Oral Tablet	PSN	3d2eb1e3-fc2b-4820-abc6-cae1228df4c2	2
312617	predniSONE 5 MG Oral Tablet	PSN	b8bb74be-9a37-44ec-a7cd-58f2cf99ac75	2
312617	predniSONE 5 MG Oral Tablet	PSN	d3abe47f-8ad5-4752-b772-97b56cca19f2	2
312617	predniSONE 5 MG Oral Tablet	PSN	3d2eb1e3-fc2b-4820-abc6-cae1228df4c2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-5338-15	00603533815	21 TABLET in 1 BOX, UNIT-DOSE (0603-5338-15)	21 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5338-21	00603533821	100 TABLET in 1 BOTTLE, PLASTIC (0603-5338-21)	100 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5338-28	00603533828	500 TABLET in 1 BOTTLE, PLASTIC (0603-5338-28)	500 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5338-31	00603533831	48 TABLET in 1 BOX, UNIT-DOSE (0603-5338-31)	48 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5338-32	00603533832	1000 TABLET in 1 BOTTLE, PLASTIC (0603-5338-32)	1000 tablet	2002-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	Par Health USA, LLC \| Generics Bidco II LLC d/b/a Prinston Laboratories \| Par Formulations Private Limited	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	35
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	A-S Medication Solutions	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	32
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	A-S Medication Solutions	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	18
PredniSONE Tablets, USP	American Health Packaging	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	10
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	Major Pharmaceuticals	2025-07-15	HUMAN PRESCRIPTION DRUG LABEL	7
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	REMEDYREPACK INC.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	15
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	Bryant Ranch Prepack	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	103
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	A-S Medication Solutions	2024-02-27	HUMAN PRESCRIPTION DRUG LABEL	28
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	A-S Medication Solutions	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	A-S Medication Solutions	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	A-S Medication Solutions	2021-08-06	HUMAN PRESCRIPTION DRUG LABEL	21
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Proficient Rx LP	2021-05-01	HUMAN PRESCRIPTION DRUG LABEL	9
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	A-S Medication Solutions	2021-03-26	HUMAN PRESCRIPTION DRUG LABEL	11
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 2.5 mg, 5 mg and 10 mg	Department of State Health Services, Pharmacy Branch	2016-02-15	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Aidarex Pharmaceuticals LLC	2013-09-29	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Physicians Total Care, Inc.	2012-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Physicians Total Care, Inc.	2012-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE TABLETS, USP 10 mg	H.J. Harkins Company, Inc. \| Qualitest Pharmaceuticals \| Sharp Corporation \| Vintage Pharmaceuticals-Charlotte \| Vintage Pharmaceuticals-Huntsville	2011-11-04	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisone tablet	RedPharm Drug Inc. \| Vintage Pharmaceuticals, LLC	2011-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 5 mg and 10 mg	Rebel Distributors Corp	2010-11-10	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	State of Florida DOH Central Pharmacy	2010-06-01	HUMAN PRESCRIPTION DRUG LABEL	1

Prednisone

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