Depo-Medrol

Product NDC: 85766-310
11-digit product format: 857660310
Labeler code: 85766
Product ID: 85766-310_5ed888e4-492e-acd3-e063-6394a90a2298
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone acetate
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler: Sportpharm LLC
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N011757-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011757-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N011757-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011757-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011757-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011757-004	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-310-01	85766031001	1 VIAL, SINGLE-DOSE in 1 PACKAGE (85766-310-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2026-10-28	No	No	Current
85766-310-25	85766031025	25 VIAL, SINGLE-DOSE in 1 PACKAGE (85766-310-25) / 1 mL in 1 VIAL, SINGLE-DOSE	2026-10-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEPO-MEDROL ® (methylprednisolone acetate injectable suspension, USP)	Sportpharm LLC	2026-10-27	HUMAN PRESCRIPTION DRUG LABEL	1