Methylprednisolone Acetate

Product NDC: 55150-313
Requested package NDC: 55150-313-25
11-digit product format: 551500313
Labeler code: 55150
Product ID: 55150-313_25c5133c-ee17-4be0-88a3-d0231e38f5a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone Acetate
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler: Eugia US LLC
Application: ANDA211930
Marketing category: ANDA
Marketing start: 2023-04-13
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211930-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2023-04-13
A211930-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2023-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211930-001	AB
A211930-002	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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211930-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211930-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-04-13	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A211930-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211930-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211930-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211930-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211930-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211930-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211930-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211930-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211930-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211930-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211930-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211930-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211930-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211930-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211930-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211930-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211930-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211930-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211930-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211930-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211930-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211930-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211930-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211930-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211930-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211930-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211930-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211930-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211930-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211930-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211930-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211930-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211930-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211930-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211930-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211930-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211930-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211930-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211930-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211930-002	AB	1	`a67488948f0b…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1358610	Internal RxNorm lookup
1358617	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
a0cbcdb5-f657-49f7-8f86-cc5959d69db0	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	SPL version
55150-313-01	Methylprednisolone Acetate	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	3
55150-313-01	Methylprednisolone Acetate	1 in 1 CARTON	INJECTION, SUSPENSION	1	3
55150-313-25	Methylprednisolone Acetate	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	3
55150-313-25	Methylprednisolone Acetate	25 in 1 CARTON	INJECTION, SUSPENSION	25	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-313-01	ML - Milliliter	55150-313	f5484818-e404-4596-9f3f-022e01c4bea9	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-313	METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [EUGIA US LLC]	1	Current NDC, 4 package rows	20230416_a0cbcdb5-f657-49f7-8f86-cc5959d69db0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone Acetate	METHYLPREDNISOLONE ACETATE	Eugia US LLC	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211930 application number: ANDA211930 ndc (package): 55150-313-25 ndc (product): 55150-313 ndc11 (package): 55150031325

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	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	3
1358617	methylPREDNISolone acetate 80 MG/ML Injectable Suspension	PSN	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	3
1358610	methylprednisolone acetate 40 MG/ML Injectable Suspension	SCD	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	3
1358617	methylprednisolone acetate 80 MG/ML Injectable Suspension	SCD	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
55150-313-25	55150031325	25 VIAL, MULTI-DOSE in 1 CARTON (55150-313-25) / 10 mL in 1 VIAL, MULTI-DOSE	2023-04-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Acetate	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2026-04-21	Human Prescription Drug Label	3