Prescription drug · ANDA
Betamethasone Sodium Phosphate and Betamethasone Acetate NDC 0517-0799
Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL · Injection, Suspension · Intra-articular, Intralesional, Intramuscular · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-0799-01 | 00517079901 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0799-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 1, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Betamethasone Sodium Phosphate and Betamethasone Acetate
- Generic name (nonproprietary)
- betamethasone sodium phosphate and betamethasone acetate
- Active ingredients
- Betamethasone acetate — 3 mg/mLBetamethasone sodium phosphate — 3 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intra-articular, Intralesional, Intramuscular
- Labeler
- American Regent, Inc.NDC labeler code 0517
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090747
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0517-0799_94369498-af74-44d3-a7f2-0f138d140d48SPL ID 94369498-af74-44d3-a7f2-0f138d140d48SPL set ID be3e57df-339a-4b7c-9528-d478af8c7855RxCUI 578803UNII TI05AO53L7, 7BK02SCL3W
- 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400517079901followed by a unit qualifier and the quantityPackage 00517-0799-01. 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)
INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hyp…
Excerpt only. Read the full label for complete information.
About NDC 0517-0799
- What is NDC 0517-0799?
- 0517-0799 is the product NDC for Betamethasone Sodium Phosphate and Betamethasone Acetate, Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL injection, suspension, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betamethasone Sodium Phosphate and Betamethasone Acetate.
- What is the active ingredient?
- Betamethasone acetate, Betamethasone sodium phosphate.
- Who is the labeler?
- American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betamethasone Sodium Phosphate and Betamethasone Acetate?
- 3 other product NDCs are listed under this name. See all Betamethasone Sodium Phosphate and Betamethasone Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betamethasone Sodium Phosphate and Betamethasone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | American Regent, Inc. | 0517-0791 | 00517-0791-01 |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | American Regent, Inc. | 0517-0720 | 00517-0720-01 |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | Asclemed USA, Inc. | 76420-007 | 76420-0007-05 |
Other NDCs under ANDA 090747
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 |
|---|---|---|---|---|
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | American Regent, Inc. | 0517-0720 |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | American Regent, Inc. | 0517-0791 |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular | Asclemed USA, Inc. | 76420-007 |