Prescription drug · ANDA

Methylprednisolone sodium succinate NDC 70518-3684

Methylprednisolone sodium succinate 125 mg/2mL · Injection · Intramuscular, Intravenous · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3684Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3684Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70518-3684-0705183684007051836840025 VIAL, SINGLE-DOSE in 1 CARTON (70518-3684-0) / 2 mL in 1 VIAL, SINGLE-DOSE (70518-3684-1)Marketed from Mar 17, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Methylprednisolone sodium succinate
Generic name (nonproprietary)
methylprednisolone sodium succinate
Active ingredients
Methylprednisolone sodium succinate — 125 mg/2mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212396
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 70518-3684_4f7f478b-3341-44cd-e063-6294a90a3ac3SPL ID 4f7f478b-3341-44cd-e063-6294a90a3ac3SPL set ID f339882f-c380-4022-bdcd-94556a7926aaRxCUI 1743704UNII LEC9GKY20K
Pharmacologic class
Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470518368400 followed by a unit qualifier and the quantity

Package 70518-3684-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema mult…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3684

What is NDC 70518-3684?
70518-3684 is the product NDC for Methylprednisolone sodium succinate, Methylprednisolone sodium succinate 125 mg/2mL injection, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methylprednisolone sodium succinate.
What is the active ingredient?
Methylprednisolone sodium succinate.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methylprednisolone sodium succinate?
27 other product NDCs are listed under this name. See all Methylprednisolone sodium succinate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methylprednisolone sodium succinate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 40 mg/1Injection, Powder, For solutionIntramuscular, IntravenousCivica, Inc.72572-09772572-0097-25
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 125 mg/1Injection, Powder, For solutionIntramuscular, IntravenousCivica, Inc.72572-09872572-0098-25
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 125 mg/1Injection, Powder, For solutionIntramuscular, IntravenousREMEDYREPACK INC.70518-434570518-4345-00
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-918200143-9182-01
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 40 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-975300143-9753-25
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 125 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-975400143-9754-25
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 40 mg/mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-12743598-0127-25
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 1 g/16mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-13043598-0130-74
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 500 mg/8mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-12843598-0128-11
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 125 mg/2mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-12943598-0129-25

All 28 Methylprednisolone sodium succinate NDCs

Other NDCs under ANDA 212396

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212396
ProductStrengthForm · routeLabelerProduct NDC
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 40 mg/mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-127
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 500 mg/8mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-128
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 125 mg/2mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-129
Methylprednisolone sodium succinateMethylprednisolone sodium succinate 1 g/16mLInjectionIntramuscular, IntravenousDr. Reddy's Laboratories Inc43598-130
Methylprednisolone Sodium SuccinateMethylprednisolone sodium succinate 125 mg/2mLInjectionIntravascular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1695
Methylprednisolone Sodium SuccinatemethylprednisoloneMethylprednisolone sodium succinate 40 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousTianjin Kingyork Pharmaceuticals Co., Ltd82094-401
Methylprednisolone Sodium SuccinatemethylprednisoloneMethylprednisolone sodium succinate 125 mg/2mLInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousTianjin Kingyork Pharmaceuticals Co., Ltd82094-402
Methylprednisolone Sodium SuccinatemethylprednisoloneMethylprednisolone sodium succinate 500 mg/8mLInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousTianjin Kingyork Pharmaceuticals Co., Ltd82094-403
Methylprednisolone Sodium SuccinatemethylprednisoloneMethylprednisolone sodium succinate 1 g/16mLInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousTianjin Kingyork Pharmaceuticals Co., Ltd82094-404
Methylprednisolone Sodium SuccinatemethylprednisoloneMethylprednisolone sodium succinate 2 g/30.6mLInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousTianjin Kingyork Pharmaceuticals Co., Ltd82094-405

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