methylprednisolone acetate

Product NDC: 85766-195
11-digit product format: 857660195
Labeler code: 85766
Product ID: 85766-195_4e657577-390a-d946-e063-6294a90ab553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone acetate
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler: Sportpharm LLC
Application: ANDA201835
Marketing category: ANDA
Marketing start: 2021-11-15
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 42.

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	Approval date
A201835-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27
A201835-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27
A201835-003	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201835-002	AB
A201835-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201835-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201835-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201835-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201835-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201835-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201835-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201835-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201835-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201835-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201835-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201835-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201835-001	AB	1	`74a2ff9319b5…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1358610	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
904b098c-9068-42ed-958f-6ab78ea42b1f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85766-195-05	methylprednisolone acetate	1 in 1 CARTON	INJECTION, SUSPENSION	1		1
85766-195-05	methylprednisolone acetate	5 mL in 1 VIAL	INJECTION, SUSPENSION	5		1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sportpharm LLC	904b098c-9068-42ed-958f-6ab78ea42b1f	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201835 application number: ANDA201835 ndc (product): 85766-195
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sagent Pharmaceuticals	f98314ea-a4e4-4f78-987b-3e9b45a08bb4	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201835 application number: ANDA201835

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
1358610	methylPREDNISolone acetate 40 MG/ML Injectable Suspension	PSN	904b098c-9068-42ed-958f-6ab78ea42b1f	1
1358610	methylprednisolone acetate 40 MG/ML Injectable Suspension	SCD	904b098c-9068-42ed-958f-6ab78ea42b1f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-195-05	85766019505	1 VIAL in 1 CARTON (85766-195-05) / 5 mL in 1 VIAL	1 vial	2026-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Acetate Injectable Suspension, USP	Sportpharm LLC	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	1