Prescription drug · ANDA
Budesonide Inhalation Suspension (Budesonide) NDC 68788-7314
Budesonide .5 mg/2mL · Inhalant · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7314-3 | 6878873140368788731403 | 6 POUCH in 1 CARTON (68788-7314-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Jan 2, 2019 |
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)
- Budesonide Inhalation SuspensionSuffix: Inhalation Suspension
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — .5 mg/2mL
- Dosage form
- Inhalant
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205710
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68788-7314_6911ba37-3588-4dd9-abdf-31ceb65be658SPL ID 6911ba37-3588-4dd9-abdf-31ceb65be658SPL set ID dcb35488-23c5-4e7b-ab86-8406cf855748RxCUI 351109UNII Q3OKS62Q6X
- 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
N468788731403followed by a unit qualifier and the quantityPackage 68788-7314-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Budesonide inhalation suspension is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( Error! Hyperlink reference not valid. ) Limitations of Use : Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : • Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
About NDC 68788-7314
- What is NDC 68788-7314?
- 68788-7314 is the product NDC for Budesonide Inhalation Suspension (budesonide), Budesonide .5 mg/2mL inhalant, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Budesonide Inhalation Suspension (Budesonide).
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Budesonide Inhalation Suspension?
- 6 other product NDCs are listed under this name. See all Budesonide Inhalation Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Budesonide Inhalation Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Budesonide Inhalation Suspensionbudesonide | Budesonide 1 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-642 | 76282-0642-38 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .25 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-640 | 76282-0640-38 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .5 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-641 | 76282-0641-38 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .25 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-318 | 69097-0318-5369097-0318-87 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .5 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-319 | 69097-0319-5369097-0319-87 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide 1 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-321 | 69097-0321-5369097-0321-87 |
Other NDCs under ANDA 205710
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 |
|---|---|---|---|---|
| Budesonide Inhalation Suspensionbudesonide | Budesonide .25 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-640 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .5 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-641 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide 1 mg/2mL | InhalantOral | Exelan Pharmaceuticals, Inc. | 76282-642 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide 1 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-321 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .25 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-318 |
| Budesonide Inhalation Suspensionbudesonide | Budesonide .5 mg/2mL | InhalantOral | Cipla USA Inc. | 69097-319 |