Prescription drug · ANDA
Dexamethasone NDC 70954-872
Dexamethasone .5 mg/5mL · Elixir · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-872-10 | 70954087210 | 1 BOTTLE in 1 CARTON (70954-872-10) / 237 mL in 1 BOTTLEMarketed from Dec 1, 2025 |
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)
- Dexamethasone
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — .5 mg/5mL
- Dosage form
- Elixir
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084754
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70954-872_5d9b22ca-c619-4ee3-98eb-74544d0d5cb3SPL ID 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3SPL set ID 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3RxCUI 309686UNII 7S5I7G3JQLUPC 0370954872108
- 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
N470954087210followed by a unit qualifier and the quantityPackage 70954-0872-10. 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 & USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, and Acute rheumatic carditis. Dermatologic Diseases Bullous dermatitis herpetiformis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe erythema multiforme (Stevens-Johnson syndrome), Severe psoriasis, and Severe seborrheic dermatitis. Edematous States To induce a diur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 084754
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 |
|---|---|---|---|---|
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Marlex Pharmaceuticals, Inc | 10135-795 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Bryant Ranch Prepack | 72162-2600 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Kesin Pharma Corporation | 81033-010 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Kanchan Healthcare Inc | 85742-004 |