Methylprednisolone Acetate

Product NDC
0703-0043
11-digit product format
007030043
Labeler code
0703
Product ID
0703-0043_57a4e988-2e4a-4615-a3f7-7ef65abd0e16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA040620
Marketing category
ANDA
Marketing start
2006-10-31
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0703-0043-01Physicians EZ Use M-pred5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION5 mL40 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-0043-01ML - Milliliter0703-0043aea15503-94d3-467a-9a4b-3f92251387d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
METHYLPREDNISOLONE ACETATEACTIVE INGREDIENT43502P7F0PPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
BUPIVACAINEACTIVE MOIETYY8335394ROPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
IODINEACTIVE MOIETY9679TC07X4PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-0043PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [PROFICIENT RX LP]1Legacy NDC20150428_f23a3dc4-62e9-46d0-a4b7-383dd5e02911.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNf626db84-9cd2-4005-8182-e2150a5a925d3
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDf626db84-9cd2-4005-8182-e2150a5a925d3
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNf23a3dc4-62e9-46d0-a4b7-383dd5e029111
1725044Marcaine 0.5 % in 10 ML InjectionPSNf23a3dc4-62e9-46d0-a4b7-383dd5e029111
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNf23a3dc4-62e9-46d0-a4b7-383dd5e029111
797730povidone-iodine 10 % Medicated PadPSNf23a3dc4-62e9-46d0-a4b7-383dd5e029111
172504410 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBDf23a3dc4-62e9-46d0-a4b7-383dd5e029111
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDf23a3dc4-62e9-46d0-a4b7-383dd5e029111
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDf23a3dc4-62e9-46d0-a4b7-383dd5e029111
797730povidone-iodine 100 MG/ML Medicated PadSCDf23a3dc4-62e9-46d0-a4b7-383dd5e029111
172504410 ML Marcaine 5 MG/ML InjectionSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111
1725044Marcaine 0.5 % in 10 ML InjectionSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111
797730povidone-iodine 10 % Medicated PadSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111
797730povidone-iodine 10 % Medicated SwabstickSYf23a3dc4-62e9-46d0-a4b7-383dd5e029111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-0043-01007030043011 VIAL, MULTI-DOSE in 1 CARTON (0703-0043-01) > 5 mL in 1 VIAL, MULTI-DOSE2006-10-310000-00-00NoNoCurrent