Over-the-counter drug · ANDA
NasalCrom (Cromolyn sodium) NDC 52183-199
Cromolyn sodium 5.2 mg/1 · Spray, Metered · Nasal · Prestige Brands Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52183-199-13 | 5218301991352183019913 | 1 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
N452183019913followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cromolyn Sodium | Cromolyn sodium 5.2 mg/1 | Spray, MeteredNasal | Bausch & Lomb Incorporated | 57782-397 |