Home › NDC Lookup › Ingredients › Ascorbic Acid, Cholecalciferol, Thiamine... › 85477-0922-30
Gestyra ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE 125 mg; 12.5 ug; 1.4 mg; 2.5 mg; 1 mg; 1000 ug; 200 mg; 13 mg; .15 mg Tablet, 30-count — NDC 85477-0922-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gestyra ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE 125 mg; 12.5 ug; 1.4 mg; 2.5 mg; 1 mg; 1000 ug; 200 mg; 13 mg; .15 mg Tablet, 30-count — NDC 85477-922-30 (Billing 85477-0922-30)

by Oncora Pharma LLC · 30 TABLET in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Gestyra ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE 125 mg; 12.5 ug; 1.4 mg; 2.5 mg; 1 mg; 1000 ug; 200 mg; 13 mg; .15 mg Tablet from Oncora Pharma LLC, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 85477-0922-30
🏷️ FDA NDC (as labeled) 85477-922-30 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 85477-922-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
85477 labeler · 922 product · 30 package
Package marketed since
Dec 22, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC)
0385477000051
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85477-922-30
Product NDC 85477-922
11-digit billing NDC 85477092230
NCPDP billing unit EA — each (per item)
UNII PQ6CK8PD0R, 1C6V77QF41, X66NSO3N35, F06SGE49M6, 935E97BOY8, BR1SN1JS2W +3 more
UPC 0385477000051
SPL Set ID f10bf225-c125-4711-893a-78e15be815bb
Established class (EPC) Vitamin C; Vitamin D
Chemical class Ascorbic Acid; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-22
Route ORAL
Dosage form TABLET
Substance ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE; POTASSIUM IODIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 78512020000320
GCN Seq No 079552
GCN 46059
HICL code 045629
Ingredient (HICL) Prenatal 147/Iron/Folic Acid
HIC1 code E
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition (C Cont)
HIC2 code E0
Therapeutic class — intermediate (HIC2) Vitamins (C6 Continued)
HIC3 code E0G
Therapeutic class — specific (HIC3) Prenatal Vitamins With Low Or No Iron
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name GESTYRA PRENATAL TABLET
FDB brand name Gestyra
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 079552
  • GCN: 46059
  • GPI-14 (Medi-Span): 78512020000320
  • HICL (First Databank): 045629
  • AHFS class code: 20:04.04.00
Why two NDCs? The FDA registers this code as 85477-922-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85477-0922-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name GESTYRA PRENATAL TABLET Ingredient Prenatal 147/Iron/Folic Acid
🧪 What is this product?

Gestyra is an oral tablet containing a combination of vitamins and minerals. It includes vitamin C (ascorbic acid), vitamin D (cholecalciferol), B vitamins (thiamine, pyridoxal phosphate, folic acid, and methylcobalamin), calcium, iron (ferrous gluconate), and iodine (potassium iodide). These ingredients are typically found in prenatal and nutritional supplement products. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85477-0922-30 You're viewing this Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2025-12-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gestyra 125 mg/1; 12.5 ug/1; 1.4 mg/1; 2.5 mg/1; 1 mg/1; 1000 ug/1; 200 mg/1; 13 mg/1; .15 mgthis 85477-0922-30 Oncora 30 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOncora Pharma LLC
Labeler code85477
First marketedDec 2025
Product typeHuman Prescription Drug

More NDCs from Oncora Pharma LLC labeler code 85477

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

INDICATIONS AND USAGE Prenatal and Postnatal prescriptive Folic Acid

⏱️ Dosage and Administration 20 words ▾

DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.

⚠️ Warnings 40 words ▾

WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.

📦 How Supplied / Storage and Handling 18 words ▾

HOW SUPPLIED Bottles of 30: 85477-922-30 Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

📦 Storage and Handling 12 words ▾

Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

📋 Description 77 words ▾

DESCRIPTION Each Tablet Contains: Amount per Tablet Vitamin C (as ascorbic acid) ............................................................................... 125 mg Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg Thiamine (as hydrochloride) ...............................................................................

1.4mg Vitamin B6 (as pyridoxal•S•phosphate) ...................................... ....................... 2.5 mg Folic Acid ............................................................................................................ 1 mg Vitamin B12 (as methylcobalamin)......................................................................

1,000 mcg Calcium (from calcium carbonate) ...................................................................... 200 mg Iron (as ferrous gluconate) ................................................................................. 13 mg Iodine (as potassium iodide...............................................................................

150 mcg OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract

⚠️ Precautions 9 words ▾

PRECAUTIONS Call your licensed medical practitioner about side effects.

📄 Package Label / Principal Display Panel 5 words ▾

PRINCIPAL DISPLAY PANEL Gestyra PDP

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Oncora Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oncora Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 85477-0921-30 · Oncora 85477-0924-30 · Oncora →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.