Prescription drug · UNAPPROVED DRUG OTHER
Embriva NDC 85477-322
Pyridoxal phosphate anhydrous 2.5 mg/1 + 8 more ingredients · Tablet · Oral · Oncora Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85477-322-30 | 8547703223085477032230 | 30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30)Marketed from Aug 8, 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)
- Embriva
- Generic name (nonproprietary)
- ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide
- Active ingredients
- Pyridoxal phosphate anhydrous — 2.5 mg/1Potassium iodide — .15 mg/1Ascorbic acid — 125 mg/1Cholecalciferol — .0125 mg/1Thiamine — 1.4 mg/1Folic acid — 1 mg/1Methylcobalamin — 1 mg/1Calcium carbonate — 200 mg/1Ferrous gluconate — 13 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oncora Pharma, LLCNDC labeler code 85477
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Ascorbic Acid (Chemical structure)Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)Vitamin D (Chemical structure)
- Identifiers
- Product ID 85477-322_3c362de4-1eda-83be-e063-6394a90a10fcSPL ID 3c362de4-1eda-83be-e063-6394a90a10fcSPL set ID 3c362de4-1ed9-83be-e063-6394a90a10fcUNII F06SGE49M6, 1C4QK22F9J, PQ6CK8PD0R, 1C6V77QF41, X66NSO3N35, 935E97BOY8, BR1SN1JS2W, H0G9379FGK, U1B11I423Z
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder; Vitamin C; Vitamin D
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
N485477032230followed by a unit qualifier and the quantityPackage 85477-0322-30. 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 Prenatal and Postnatal prescriptive Folic Acid
Excerpt only. Read the full label for complete information.
About NDC 85477-322
- What is NDC 85477-322?
- 85477-322 is the product NDC for Embriva, Pyridoxal phosphate anhydrous 2.5 mg/1 + 8 more ingredients tablet, listed with the FDA by Oncora Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Embriva (Ascorbic acid, Cholecalciferol, Thiamine, Pyridoxal phosphate, Folic acid, Methylcobalamin, Calcium carbonate, Ferrous gluconate, Potassium iodide).
- What is the active ingredient?
- Pyridoxal phosphate anhydrous, Potassium iodide, Ascorbic acid, Cholecalciferol, Thiamine, Folic acid, Methylcobalamin, Calcium carbonate, Ferrous gluconate.
- Who is the labeler?
- Oncora Pharma, LLC, NDC labeler code 85477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Embriva?
- 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.