NDC codes

FDA NDC Directory
Product NDC (as listed)52183-199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52183-0199Add 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
52183-199-1352183019913521830199131 BOTTLE, PUMP in 1 CARTON (52183-199-13) / 200 SPRAY, METERED in 1 BOTTLE, PUMPMarketed from Oct 29, 2009

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)
NasalCrom
Generic name (nonproprietary)
cromolyn sodium
Active ingredients
Cromolyn sodium — 5.2 mg/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Prestige Brands Holdings, Inc.NDC labeler code 52183
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075702
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)
Identifiers
Product ID 52183-199_0a2a4a89-e8ee-46a0-8187-3e1192c39985SPL ID 0a2a4a89-e8ee-46a0-8187-3e1192c39985SPL set ID b34d36ca-4df4-458c-af0f-c0d0c9a025d9RxCUI 1797851, 1797853UNII Q2WXR1I0PK
Pharmacologic class
Mast Cell Stabilizer

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

N452183019913 followed by a unit qualifier and the quantity

Package 52183-0199-13. 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)

Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: runny/itchy nose sneezing allergic stuffy nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52183-199

What is NDC 52183-199?
52183-199 is the product NDC for NasalCrom (cromolyn sodium), Cromolyn sodium 5.2 mg/1 spray, metered, listed with the FDA by Prestige Brands Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
NasalCrom (Cromolyn sodium).
What is the active ingredient?
Cromolyn sodium.
Who is the labeler?
Prestige Brands Holdings, Inc., NDC labeler code 52183. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for NasalCrom?
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.

Other NDCs under ANDA 075702

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

FDA NDC Directory listings under ANDA 075702
ProductStrengthForm · routeLabelerProduct NDC
Cromolyn SodiumCromolyn sodium 5.2 mg/1Spray, MeteredNasalBausch & Lomb Incorporated57782-397

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