NDC codes

FDA NDC Directory
Product NDC (as listed)68382-919Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0919Add 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
68382-919-016838209190168382091901100 TABLET in 1 BOTTLE (68382-919-01)Marketed from May 1, 2018
68382-919-056838209190568382091905500 TABLET in 1 BOTTLE (68382-919-05)Marketed from May 1, 2018
68382-919-11683820919116838209191125 TABLET in 1 BOTTLE (68382-919-11)Marketed from May 1, 2018
68382-919-77683820919776838209197710 BLISTER PACK in 1 CARTON (68382-919-77) / 10 TABLET in 1 BLISTER PACK (68382-919-30)Marketed from May 1, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary)
methylprednisolone
Active ingredients
Methylprednisolone — 32 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206751
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 68382-919_6cebff10-362f-41a7-8f66-3d9e878760fdSPL ID 6cebff10-362f-41a7-8f66-3d9e878760fdSPL set ID eaa9c932-c659-4ef6-bf5a-186545d87320RxCUI 197971, 197973, 259966, 328161, 762675UNII X4W7ZR7023
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468382091901 followed by a unit qualifier and the quantity

Package 68382-0919-01. 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 Methylprednisolone tablets are indicated in the following conditions: 1.Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-919

What is NDC 68382-919?
68382-919 is the product NDC for methylprednisolone, Methylprednisolone 32 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
methylprednisolone.
What is the active ingredient?
Methylprednisolone.
Who is the labeler?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?
48 other product NDCs are listed under this name. See all methylprednisolone 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
methylprednisoloneMethylprednisolone 4 mg/1TabletOralBluePoint Laboratories68001-62468001-0624-01
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralREMEDYREPACK INC.70518-421370518-4213-00
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-96160760-0961-21
methylprednisoloneMethylprednisolone 4 mg/1TabletOralREMEDYREPACK INC.70518-362270518-3622-01
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-023080425-0230-01
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-023180425-0231-01
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-025580425-0255-01
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralDirect_Rx72189-26472189-0264-21
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-783368788-7833-02
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralREMEDYREPACK INC.70518-286470518-2864-00

All 49 methylprednisolone NDCs

Other NDCs under ANDA 206751

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

FDA NDC Directory listings under ANDA 206751
ProductStrengthForm · routeLabelerProduct NDC
methylprednisoloneMethylprednisolone 4 mg/1TabletOralMajor Pharmaceuticals0904-6914
methylprednisoloneMethylprednisolone 4 mg/1TabletOralA-S Medication Solutions50090-3811
methylprednisoloneMethylprednisolone 4 mg/1TabletOralBluePoint Laboratories68001-624
methylprednisoloneMethylprednisolone 4 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-916
methylprednisoloneMethylprednisolone 8 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-917
methylprednisoloneMethylprednisolone 16 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-918
methylprednisoloneMethylprednisolone 4 mg/1TabletOralREMEDYREPACK INC.70518-3622
methylprednisoloneMethylprednisolone 4 mg/1TabletOralZydus Lifesciences Limited70771-1348
methylprednisoloneMethylprednisolone 8 mg/1TabletOralZydus Lifesciences Limited70771-1349
methylprednisoloneMethylprednisolone 16 mg/1TabletOralZydus Lifesciences Limited70771-1350
methylprednisoloneMethylprednisolone 32 mg/1TabletOralZydus Lifesciences Limited70771-1351
MethylprednisoloneMethylprednisolone 4 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0231
methylprednisoloneMethylprednisolone 4 mg/1TabletOralProficient Rx LP82804-007

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