Prescription drug · ANDA
Beclomethasone Dipropionate NDC 69238-1289
Beclomethasone dipropionate 40 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1289-4 | 69238128904 | 1 CANISTER in 1 CARTON (69238-1289-4) / 120 AEROSOL, METERED in 1 CANISTERMarketed from Dec 17, 2025 |
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)
- Beclomethasone Dipropionate
- Generic name (nonproprietary)
- beclomethasone dipropionate
- Active ingredients
- Beclomethasone dipropionate — 40 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213811
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69238-1289_e351b5e4-d97c-4b2b-8d12-ca34987d2b88SPL ID e351b5e4-d97c-4b2b-8d12-ca34987d2b88SPL set ID d853c96f-21a3-4def-931d-4d47d16acd62RxCUI 1490666, 1490773UNII 5B307S63B2
- 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.
- NDC on a medical claim
N469238128904followed by a unit qualifier and the quantityPackage 69238-1289-04. 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)
Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1)
Excerpt only. Read the full label for complete information.
About NDC 69238-1289
- What is NDC 69238-1289?
- 69238-1289 is the product NDC for Beclomethasone Dipropionate, Beclomethasone dipropionate 40 ug/1 aerosol, metered, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Beclomethasone Dipropionate.
- What is the active ingredient?
- Beclomethasone dipropionate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Beclomethasone Dipropionate?
- 3 other product NDCs are listed under this name. See all Beclomethasone Dipropionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Beclomethasone Dipropionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Beclomethasone Dipropionate | Beclomethasone dipropionate 40 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Aurolife Pharma LLC | 13107-230 | 13107-0230-54 |
| Beclomethasone Dipropionate | Beclomethasone dipropionate 80 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Aurolife Pharma LLC | 13107-231 | 13107-0231-54 |
| Beclomethasone Dipropionate | Beclomethasone dipropionate 80 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Amneal Pharmaceuticals NY LLC | 69238-1290 | 69238-1290-04 |
Other NDCs under ANDA 213811
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 |
|---|---|---|---|---|
| Beclomethasone Dipropionate | Beclomethasone dipropionate 80 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Amneal Pharmaceuticals NY LLC | 69238-1290 |