Prednisone

Product NDC: 0603-5337
11-digit product format: 006035337
Labeler code: 0603
Product ID: 0603-5337_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: 5 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	5 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
0603-5337-15	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
0603-5337-15	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
0603-5337-21	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
0603-5337-21	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
0603-5337-31	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
0603-5337-31	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
0603-5337-32	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
0603-5337-32	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
0603-5337-15	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
0603-5337-15	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
0603-5337-21	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
0603-5337-21	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
0603-5337-31	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
0603-5337-31	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
0603-5337-32	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
0603-5337-32	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
0603-5337-15	Prednisone	21 in 1 BOX, UNIT-DOSE	TABLET	21	32
0603-5337-21	Prednisone	100 in 1 BOTTLE, PLASTIC	TABLET	100	32
0603-5337-31	Prednisone	48 in 1 BOX, UNIT-DOSE	TABLET	48	32
0603-5337-32	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
0603-5337-15	EA - Each	0603-5337	fd62a8b4-6ab8-41b6-9fb4-570ae2656eff	1	2012-07-24
0603-5337-21	EA - Each	0603-5337	a2a776cd-74c6-461f-a4b0-c29f15d92186	1	2012-07-24
0603-5337-31	EA - Each	0603-5337	72dda4d8-26e6-496e-9c69-e82c85baf6b0	1	2012-07-24
0603-5337-32	EA - Each	0603-5337	530950bb-6e20-46ee-a3aa-a4b341075c7e	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 [BLENHEIM PHARMACAL, INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [BRYANT RANCH PREPACK]	2
prednisone	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]	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 [BLENHEIM PHARMACAL, INC.]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [BRYANT RANCH PREPACK]	2
prednisone	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	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 [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	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 [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [BLENHEIM PHARMACAL, 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 [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [MEDVANTX, INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, 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 [DISPENSING SOLUTIONS INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DIRECT RX]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [STAT RX USA LLC]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [MEDVANTX, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DIRECT RX]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [STAT RX USA LLC]	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
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	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 [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [MEDVANTX, 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 [AIDAREX PHARMACEUTICALS LLC]	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 [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	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
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DISPENSING SOLUTIONS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [STAT RX USA LLC]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DIRECT RX]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-5337	PREDNISONE TABLET [ENDO USA, INC.]	32	Current NDC, Legacy NDC, 4 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
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	dc3bbb97-6588-46f4-b0ad-47596874ad0c	107
312617	predniSONE 5 MG Oral Tablet	PSN	dc3bbb97-6588-46f4-b0ad-47596874ad0c	107
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	dc3bbb97-6588-46f4-b0ad-47596874ad0c	107
312617	prednisone 5 MG Oral Tablet	SCD	dc3bbb97-6588-46f4-b0ad-47596874ad0c	107
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	dc3bbb97-6588-46f4-b0ad-47596874ad0c	107
312617	predniSONE 5 MG Oral Tablet	PSN	931171e2-0bdb-451e-b737-72ce3ffbed53	104
312617	prednisone 5 MG Oral Tablet	SCD	931171e2-0bdb-451e-b737-72ce3ffbed53	104
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
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	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
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
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
312617	prednisone 5 MG Oral Tablet	SCD	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	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	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
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	71295010-5adb-499b-a03a-5c78b5e79b2d	17
312617	predniSONE 5 MG Oral Tablet	PSN	71295010-5adb-499b-a03a-5c78b5e79b2d	17
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	71295010-5adb-499b-a03a-5c78b5e79b2d	17
312617	prednisone 5 MG Oral Tablet	SCD	71295010-5adb-499b-a03a-5c78b5e79b2d	17
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	71295010-5adb-499b-a03a-5c78b5e79b2d	17
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	746b0bcd-122e-4ea8-a824-28415073a38e	13
312617	predniSONE 5 MG Oral Tablet	PSN	746b0bcd-122e-4ea8-a824-28415073a38e	13
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	746b0bcd-122e-4ea8-a824-28415073a38e	13
312617	prednisone 5 MG Oral Tablet	SCD	746b0bcd-122e-4ea8-a824-28415073a38e	13
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	746b0bcd-122e-4ea8-a824-28415073a38e	13
312617	predniSONE 5 MG Oral Tablet	PSN	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	11
312617	prednisone 5 MG Oral Tablet	SCD	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	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
312617	predniSONE 5 MG Oral Tablet	PSN	290a91e5-22ae-4d62-ab34-39a3117002e2	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
312617	prednisone 5 MG Oral Tablet	SCD	290a91e5-22ae-4d62-ab34-39a3117002e2	9
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	2a053775-6f6a-455e-b9a8-8b60e6062db3	5
312617	predniSONE 5 MG Oral Tablet	PSN	2a053775-6f6a-455e-b9a8-8b60e6062db3	5
312617	predniSONE 5 MG Oral Tablet	PSN	78b919b1-5435-46ae-896c-19780343ebff	5
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	2a053775-6f6a-455e-b9a8-8b60e6062db3	5
312617	prednisone 5 MG Oral Tablet	SCD	2a053775-6f6a-455e-b9a8-8b60e6062db3	5
312617	prednisone 5 MG Oral Tablet	SCD	78b919b1-5435-46ae-896c-19780343ebff	5
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	2a053775-6f6a-455e-b9a8-8b60e6062db3	5
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-5337-15	00603533715	21 TABLET in 1 BOX, UNIT-DOSE (0603-5337-15)	21 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5337-21	00603533721	100 TABLET in 1 BOTTLE, PLASTIC (0603-5337-21)	100 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5337-31	00603533731	48 TABLET in 1 BOX, UNIT-DOSE (0603-5337-31)	48 tablet	2002-07-12	0000-00-00	No	No	Current
0603-5337-32	00603533732	1000 TABLET in 1 BOTTLE, PLASTIC (0603-5337-32)	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	DIRECT RX	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	5
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	A-S Medication Solutions	2026-03-07	HUMAN PRESCRIPTION DRUG LABEL	17
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 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	REMEDYREPACK INC.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	13
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	Preferred Pharmaceuticals, Inc.	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	11
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	107
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	104
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	9
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
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	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Aphena Pharma Solutions - Tennessee, LLC	2017-12-21	HUMAN PRESCRIPTION DRUG LABEL	1
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 5 mg	Blenheim Pharmacal, Inc. \| Blenheim Pharmacal, Inc	2015-02-13	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Aidarex Pharmaceuticals LLC	2014-04-02	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 (D/P) TABLETS, USP 5 mg	STAT Rx USA LLC \| PSS World Medical Inc.	2012-10-08	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	H.J. Harkins Company, Inc. \| Sharp Corporation \| Vintage Pharmaceuticals-Charlotte \| Vintage Pharmaceuticals-Huntsville	2012-08-24	HUMAN PRESCRIPTION DRUG LABEL	1
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

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#