What is NDC 50458-028?

50458-028 is the product NDC for Spravato (esketamine hydrochloride), Esketamine hydrochloride 28 mg/.2mL solution, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Spravato (Esketamine Hydrochloride).

Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Spravato?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Spravato NDC 50458-028 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-028Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0028Add 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 NDC	11-digit (billing)	Package	Copy
50458-028-02	50458002802	2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)Marketed from Mar 5, 2019
50458-028-03	50458002803	3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)Marketed from Mar 5, 2019

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): Spravato
Generic name (nonproprietary): esketamine hydrochloride
Active ingredients: Esketamine hydrochloride — 28 mg/.2mL
Dosage form: Solution
Route: Nasal
Labeler: Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211243
Marketing start: Mar 5, 2019
Listing expires: Dec 31, 2027
DEA schedule: CIII
Identifiers: Product ID 50458-028_9731f316-79b8-41c8-a056-c1f1dc65f0efSPL ID 9731f316-79b8-41c8-a056-c1f1dc65f0ef

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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450458002802 followed by a unit qualifier and the quantity

Package 50458-0028-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 50458-028

What is NDC 50458-028?: 50458-028 is the product NDC for Spravato (esketamine hydrochloride), Esketamine hydrochloride 28 mg/.2mL solution, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Spravato (Esketamine Hydrochloride).
What is the active ingredient?: Esketamine hydrochloride.
Who is the labeler?: Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Spravato?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Spravato (Esketamine hydrochloride) NDC 50458-028