Medrol

Product NDC: 0009-0056
11-digit product format: 000090056
Labeler code: 0009
Product ID: 0009-0056_e4a8e5b4-af77-4eca-92de-cd0982969b82
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA011153
Marketing category: NDA
Marketing start: 1957-10-24
Substance: METHYLPREDNISOLONE
Active strength: 4 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 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011153-001	MEDROL	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-002	MEDROL	METHYLPREDNISOLONE	2MG	TABLET / ORAL		RLD, Approved before 1982
N011153-003	MEDROL	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-004	MEDROL	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-005	MEDROL	METHYLPREDNISOLONE	24MG	TABLET / ORAL		Approved before 1982
N011153-006	MEDROL	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N011153-001	AB
N011153-003	AB
N011153-004	AB
N011153-006	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	RLD / RS	Source SHA-256
2026-08-01 22:54:32	2026-06	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N011153-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011153-006	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	Mylan Pharmaceuticals Inc.	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153
Methylprednisolone	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	bdd233d9-333d-7389-e053-2a95a90a4b42	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153
Medrol	METHYLPREDNISOLONE	Pharmacia & Upjohn Company LLC	39d5270b-d957-4821-93d6-501b7b9f02d4	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153 ndc (product): 0009-0056
Methylprednisolone	METHYLPREDNISOLONE	REMEDYREPACK INC.	d2a0e52c-f724-40e6-9d2a-5f1487c104b6	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153

Additional Listing Data#

Finished product: Yes
Brand name base: Medrol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4W7ZR7023	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197969	Internal RxNorm lookup
197971	Internal RxNorm lookup
197973	Internal RxNorm lookup
207136	Internal RxNorm lookup
207137	Internal RxNorm lookup
207138	Internal RxNorm lookup
207141	Internal RxNorm lookup
259966	Internal RxNorm lookup
260330	Internal RxNorm lookup
328161	Internal RxNorm lookup
762675	Internal RxNorm lookup
834023	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
39d5270b-d957-4821-93d6-501b7b9f02d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26	Product name	5	20260128
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0009-0056-02	Medrol	100 in 1 BOTTLE	TABLET	100	25
0009-0056-04	Medrol	1 in 1 CARTON	TABLET	1	25
0009-0056-04	Medrol	21 in 1 DOSE PACK	TABLET	21	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0056-02	EA - Each	0009-0056	311a950b-c6f3-4823-b077-776d91412efb	1	2012-07-24
0009-0056-04	EA - Each	0009-0056	ddf885dd-f182-49fa-b3c4-e7208e090650	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPREDNISOLONE	ACTIVE INGREDIENT	X4W7ZR7023	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]	7
methylprednisolone	ACTIVE INGREDIENT	X4W7ZR7023	MEDROL (METHYLPREDNISOLE) TABLET [STAT RX USA]	2
methylprednisolone	ACTIVE MOIETY	X4W7ZR7023	MEDROL (METHYLPREDNISOLE) TABLET [STAT RX USA]	2
METHYLPREDNISOLONE	ACTIVE INGREDIENT	X4W7ZR7023	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-0056	MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]	24	Current NDC, Legacy NDC, 3 package rows	20250424_39d5270b-d957-4821-93d6-501b7b9f02d4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4W7ZR7023	METHYLPREDNISOLONE	83-43-2	METHYLPREDNISOLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834023	{21 (methylprednisolone 4 MG Oral Tablet [Medrol]) } Pack [Medrol Dosepak]	BPCK	39d5270b-d957-4821-93d6-501b7b9f02d4	25
762675	{21 (methylprednisolone 4 MG Oral Tablet) } Pack	GPCK	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207138	Medrol 16 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207136	Medrol 2 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207141	Medrol 32 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
260330	Medrol 4 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207137	Medrol 8 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
834023	Medrol Dosepak 4 MG Tablet 6 Day 21 Count Pack	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
328161	methylPREDNISolone 16 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197969	methylPREDNISolone 2 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197971	methylPREDNISolone 32 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197973	methylPREDNISolone 8 MG Oral Tablet	PSN	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207138	methylprednisolone 16 MG Oral Tablet [Medrol]	SBD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207136	methylprednisolone 2 MG Oral Tablet [Medrol]	SBD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207141	methylprednisolone 32 MG Oral Tablet [Medrol]	SBD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
260330	methylprednisolone 4 MG Oral Tablet [Medrol]	SBD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207137	methylprednisolone 8 MG Oral Tablet [Medrol]	SBD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
328161	methylprednisolone 16 MG Oral Tablet	SCD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197969	methylprednisolone 2 MG Oral Tablet	SCD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197971	methylprednisolone 32 MG Oral Tablet	SCD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
259966	methylprednisolone 4 MG Oral Tablet	SCD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
197973	methylprednisolone 8 MG Oral Tablet	SCD	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207138	Medrol 16 MG Oral Tablet	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207136	Medrol 2 MG Oral Tablet	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207141	Medrol 32 MG Oral Tablet	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
260330	Medrol 4 MG Oral Tablet	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
207137	Medrol 8 MG Oral Tablet	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
834023	Medrol Dosepak	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	39d5270b-d957-4821-93d6-501b7b9f02d4	25
834023	{21 (methylprednisolone 4 MG Oral Tablet [Medrol]) } Pack [Medrol Dosepak]	BPCK	080a1789-f2d0-4d31-aa63-08cd703c7779	15
762675	{21 (methylprednisolone 4 MG Oral Tablet) } Pack	GPCK	080a1789-f2d0-4d31-aa63-08cd703c7779	15
260330	Medrol 4 MG Oral Tablet	PSN	080a1789-f2d0-4d31-aa63-08cd703c7779	15
834023	Medrol Dosepak 4 MG Tablet 6 Day 21 Count Pack	PSN	080a1789-f2d0-4d31-aa63-08cd703c7779	15
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	080a1789-f2d0-4d31-aa63-08cd703c7779	15
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	080a1789-f2d0-4d31-aa63-08cd703c7779	15
260330	methylprednisolone 4 MG Oral Tablet [Medrol]	SBD	080a1789-f2d0-4d31-aa63-08cd703c7779	15
259966	methylprednisolone 4 MG Oral Tablet	SCD	080a1789-f2d0-4d31-aa63-08cd703c7779	15
260330	Medrol 4 MG Oral Tablet	SY	080a1789-f2d0-4d31-aa63-08cd703c7779	15
834023	Medrol Dosepak	SY	080a1789-f2d0-4d31-aa63-08cd703c7779	15
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	080a1789-f2d0-4d31-aa63-08cd703c7779	15
260330	Medrol 4 MG Oral Tablet	PSN	4c0dd824-b099-47c3-aaf5-f6ddb873b3ee	2
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	4c0dd824-b099-47c3-aaf5-f6ddb873b3ee	2
260330	methylprednisolone 4 MG Oral Tablet [Medrol]	SBD	4c0dd824-b099-47c3-aaf5-f6ddb873b3ee	2
259966	methylprednisolone 4 MG Oral Tablet	SCD	4c0dd824-b099-47c3-aaf5-f6ddb873b3ee	2
260330	Medrol 4 MG Oral Tablet	SY	4c0dd824-b099-47c3-aaf5-f6ddb873b3ee	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-0056-02	00009005602	100 TABLET in 1 BOTTLE (0009-0056-02)	100 tablet	1957-10-24	0000-00-00	No	No	Current
0009-0056-04	00009005604	1 DOSE PACK in 1 CARTON (0009-0056-04) / 21 TABLET in 1 DOSE PACK	1 dose pack	1957-10-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Medrol ® methylprednisolone tablets, USP	Pharmacia & Upjohn Company LLC \| Pfizer Italia S.r.l.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	25
Medrol ® methylprednisolone tablets, USP	A-S Medication Solutions	2020-06-24	HUMAN PRESCRIPTION DRUG LABEL	15
Medrol ® methylprednisolone tablets, USP	REMEDYREPACK INC.	2019-11-11	HUMAN PRESCRIPTION DRUG LABEL	3
Medrol - Stat Rx USA	Stat Rx USA	2010-04-01	HUMAN PRESCRIPTION DRUG LABEL	2