Methylprednisolone acetate

Product NDC
70121-1574
11-digit product format
701211574
Labeler code
70121
Product ID
70121-1574_af4215ff-94ca-44f8-8506-3024e738cd13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210043
Marketing category
ANDA
Marketing start
2019-05-20
Substance
METHYLPREDNISOLONE ACETATE
Active strength
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1743779, 1743855

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1574-1Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-1Methylprednisolone acetate1 in 1 CARTONINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate25 in 1 CARTONINJECTION, SUSPENSION2516
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL11
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL11
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1574-1ML - Milliliter70121-157468b0e5e7-e814-4c98-a6e5-02085339b85812020-08-06
70121-1574-5ML - Milliliter70121-157458ac78fc-2bd4-458a-8aa3-f905f328b61812020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Methylprednisolone AcetateACTIVE INGREDIENT43502P7F0PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
BupivacaineACTIVE MOIETYY8335394RODYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
LidocaineACTIVE MOIETY98PI200987DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1574METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 4 package rows20250108_d944240d-2c19-46ba-ad4f-3fbee7b8629c.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20241008_e9f7f923-e7f9-4c52-b56d-914d800c1acf.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]5Current NDC, Legacy NDC20241008_c4071146-7d89-4c3a-9278-389d801cf66d.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca7a2d-e8cb-c063-e063-6294a90ae7f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSNd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNd944240d-2c19-46ba-ad4f-3fbee7b8629c16
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCDd944240d-2c19-46ba-ad4f-3fbee7b8629c16
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSYd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Medicated PadPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated PadPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637sodium chloride 0.9 % in 10 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807638sodium chloride 0.9 % in 20 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807631sodium chloride 0.9 % in 50 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763710 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763820 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763150 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 100 MG/ML Medicated PadSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763710 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763820 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763150 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Topical ClothSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Topical SwabSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 1 % per 5 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637normal saline 10 mL InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated SwabstickSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637sodium chloride 0.9 % per 10 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807638sodium chloride 0.9 % per 20 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807631sodium chloride 0.9 % per 50 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN2f47d739-c39f-47c2-9e3c-1aef2cf201b18
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCD2f47d739-c39f-47c2-9e3c-1aef2cf201b18
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSY2f47d739-c39f-47c2-9e3c-1aef2cf201b18
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Medicated PadPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 1 % in 5 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated PadPSNc4071146-7d89-4c3a-9278-389d801cf66d5
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 100 MG/ML Medicated PadSCDc4071146-7d89-4c3a-9278-389d801cf66d5
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Topical ClothSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Topical SwabSYc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 1 % per 5 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 50 MG per 5 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated SwabstickSYc4071146-7d89-4c3a-9278-389d801cf66d5
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
797544isopropyl alcohol 70 % Medicated PadPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
797544isopropyl alcohol 70 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1737566lidocaine HCl 1 % in 5 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1737566lidocaine HCl 1 % in 5 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1574-1701211574011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-200000-00-00NoNoCurrent
70121-1574-57012115740525 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-5) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-200000-00-00NoNoCurrent