DEPO-MEDROL

Product NDC: 50090-0556
11-digit product format: 500900556
Labeler code: 50090
Product ID: 50090-0556_82776182-5ffe-4380-8eb3-498f27c9a834
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone acetate
Dosage form: INJECTION, SUSPENSION
Route: INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler: A-S Medication Solutions
Application: NDA011757
Marketing category: NDA
Marketing start: 1959-05-28
Substance: METHYLPREDNISOLONE ACETATE
Active strength: 40 mg/mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011757-001	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982
N011757-002	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N011757-004	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N011757-001	AB
N011757-004	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 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	N011757-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011757-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011757-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011757-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011757-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011757-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011757-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011757-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011757-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011757-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011757-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011757-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011757-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011757-004	AB	1	`74a2ff9319b5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE ACETATE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43502P7F0P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1358610	Internal RxNorm lookup
1358612	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
aa151d12-bd33-4d26-848f-2195172c9700	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0556-0	2023-05-10	C162847	48780-1	f386c649-9a76-0266-e053-dadaa90a7c1a	DEPO-MEDROL
50090-0556-0	2023-01-30	C162847	48780-1	f386c649-9a76-0266-e053-dadaa90a7c1a	DEPO-MEDROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0556-0	DEPO-MEDROL	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0556-0	ML - Milliliter	50090-0556	0aaf6f8b-71f4-4259-8f1b-0f4284ff4591	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0556	DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]	19	Current NDC, Legacy NDC, 1 package rows	20240612_aa151d12-bd33-4d26-848f-2195172c9700.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	823b0010-2b57-4e76-b5ac-4a8c2963438f	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	9a7b3837-e038-48bf-97e9-78ad463760dc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	bf1b104d-85cb-414d-a366-78068c82c883	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	cb457bef-8823-4f3c-987b-eb0922494c46	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	d75f6751-9ac3-416f-8470-6c011aacf755	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	e8209047-c1e6-4081-a6d3-c603d9ee4f14	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	aa151d12-bd33-4d26-848f-2195172c9700	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 50090-0556
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Asclemed USA, Inc.	cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43502P7F0P	METHYLPREDNISOLONE ACETATE	53-36-1	METHYLPREDNISOLONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1358612	DEPO-Medrol 40 MG/ML Injectable Suspension	PSN	aa151d12-bd33-4d26-848f-2195172c9700	19
1358610	methylPREDNISolone acetate 40 MG/ML Injectable Suspension	PSN	aa151d12-bd33-4d26-848f-2195172c9700	19
1358612	methylprednisolone acetate 40 MG/ML Injectable Suspension [Depo-Medrol]	SBD	aa151d12-bd33-4d26-848f-2195172c9700	19
1358610	methylprednisolone acetate 40 MG/ML Injectable Suspension	SCD	aa151d12-bd33-4d26-848f-2195172c9700	19
1358612	Depo-Medrol 40 MG/ML Injectable Suspension	SY	aa151d12-bd33-4d26-848f-2195172c9700	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0556-0	50090055600	10 mL in 1 VIAL, MULTI-DOSE (50090-0556-0)	10 ml	2016-06-29	0000-00-00	No	No	Current