HomeNDC LookupIngredientsFolic Acid › 11534-0165-03
FOLIC ACID 1 mg Tablet, 1,000-count — NDC 11534-0165-03 package photo

FOLIC ACID 1 mg Tablet, 1,000-count

by SUNRISE PHARMACEUTICAL, INC. · 1000 TABLET in 1 BOTTLE (11534-165-03)
NDC 11534-0165-03
🏷️ FDA NDC (as labeled) 11534-165-03 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0194 NADAC Per package$19.40 / 1000 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2167/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 11534-165-03
Product NDC 11534-165
11-digit billing NDC 11534016503
NCPDP billing unit EA — each (per item)
RxCUI 310410
UNII 935E97BOY8
Application # ANDA204418
SPL Set ID 6854412b-7ecb-4107-85eb-730f14e23f06
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-08-04
Route ORAL
Dosage form TABLET
Substance FOLIC ACID
GPI-14 82200010000315
GPI class Folic Acid
GCN Seq No 002366
GCN 94781
HICL code 001062
Ingredient (HICL) Folic Acid
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6M
Therapeutic class — specific (HIC3) Folic Acid Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name FOLIC ACID 1 MG TABLET
FDB brand name Folic Acid
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 11534-165-03 — 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 → 11534-0165-03. 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.

🏷️ RxNorm drug class

This medicine belongs to the Folic acid and derivatives class.

Drug family (ATC) Folic acid and derivatives, Other diagnostic agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSUNRISE PHARMACEUTICAL, INC.
Application holderNUVO PHAMACEUTICALS INC
FDA applicationANDA204418 (ANDA)
Labeler code11534
First marketedAug 2015
Product typeHuman Prescription Drug
Portfolio26 products on file
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.

🩺 Clinical

Label name FOLIC ACID 1 MG TABLET Ingredient Folic Acid
📖 What it is MedlinePlus · NLM

Folic acid is used to treat or prevent folic acid deficiency. It is a B-complex vitamin needed by the body to manufacture red blood cells. A deficiency of this vitamin causes certain types of anemia (low red blood cell count).

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Folic acid is a B vitamin, but when prescribed at therapeutic doses it's treating a specific medical condition: megaloblastic anemia caused by folic acid deficiency. This is a type...
  • What exactly is folic acid being used for — is it just a vitamin?
  • The oral solution — both Folic Acid oral solution and Quiofic — can be taken with or without food, so take it whichever way works best for you. If you're using the oral solution, m...
  • Can I take folic acid on an empty stomach, or does it need to be taken with food?
📖 Read our full Folic Acid guide →
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.

💊 What it looks like

Color Yellow
ShapeRound
ImprintN;8
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

4 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 DailyMedingredient 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.019 $19.40 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.2167 $216.70 / 1000 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.032 $0.019
▼ Down 26% over the last 24 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folic Acid 1 mg 00904-7224-61 Major 100 tablets $0.019 AA Availability likely
Folic Acid 1 mgthis 11534-0165-03 SUNRISE 1000 tablets $0.019 AA Availability likely
Folic Acid 1 mg 16571-0881-01 Rising 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 53746-0361-01 Amneal 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 58657-0151-01 Method 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 60687-0681-01 American 100 tablets $0.019 AA Availability likely
Folic acid 1 mg 62135-0210-01 Chartwell 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 69315-0127-01 Leading 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 70752-0231-10 QUAGEN 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 72241-0050-05 Modavar 100 tablets $0.019 AA Availability likely
Folic Acid 1 mg 00615-8589-05 NCS 15 tablets AA FDA listed
Folic Acid 1 mg 43063-0791-30 PD-Rx 30 tablets AA FDA listed
Folic Acid 1 mg 50090-3119-00 A-S 100 tablets AA FDA listed
Folic Acid 1 mg 50090-6760-00 A-S 90 tablets AA FDA listed
Folic Acid 1 mg 50090-7194-00 A-S 100 tablets AA FDA listed
Folic Acid 1 mg 50090-7195-00 A-S 90 tablets AA FDA listed
Folic Acid 1 mg 55154-2137-00 Cardinal 10 tablets AA FDA listed
Folic Acid 1 mg 55154-4306-00 Cardinal 10 tablets AA FDA listed
Folic Acid 1 mg 63629-9257-01 Bryant 100 tablets AA FDA listed
Folic Acid 1 mg 63629-9258-01 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 65162-0361-01 Amneal 10 tablets AA FDA listed
Folic Acid 1 mg 66267-0217-30 NuCare 30 tablets AA FDA listed
Folic Acid 1 mg 67046-0719-03 Coupler 30 tablets AA FDA listed
Folic Acid 1 mg 67046-1449-03 Coupler 30 tablets AA FDA listed
Folic Acid 1 mg 68071-2992-01 NuCare 100 tablets AA FDA listed
Folic Acid 1 mg 68071-3513-01 NuCare 100 tablets AA FDA listed
Folic Acid 1 mg 68071-4602-01 NuCare 100 tablets AA FDA listed
Folic Acid 1 mg 68788-8557-01 Preferred 100 tablets AA FDA listed
Folic Acid 1 mg 68788-8827-01 Preferred 100 tablets AA FDA listed
Folic Acid 1 mg 70518-4338-00 REMEDYREPACK 100 tablets AA FDA listed
Folic Acid 1 mg 70518-4459-00 REMEDYREPACK 30 tablets AA FDA listed
Folic Acid 1 mg 71205-0913-00 Proficient 100 tablets AA FDA listed
Folic Acid 1 mg 71209-0007-05 Cadila 100 tablets AA FDA listed
Folic Acid 1 mg 71335-0613-01 Bryant 30 tablets AA FDA listed
Folic Acid 1 mg 71335-0766-01 Bryant 30 tablets AA FDA listed
Folic Acid 1 mg 71335-2547-01 Bryant 30 tablets AA FDA listed
Folic Acid 1 mg 71335-2849-01 Bryant 30 tablets AA FDA listed
Folic Acid 1 mg 71335-2858-01 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 71335-9628-01 Bryant 30 tablets AA FDA listed
Folic Acid 1 mg 71610-0235-30 Aphena 30 tablets AA FDA listed
Folic acid 1 mg 71610-0545-30 Aphena 30 tablets AA FDA listed
Folic Acid 1 mg 71610-0656-30 Aphena 30 tablets AA FDA listed
Folic Acid 1 mg 71610-0716-30 Aphena 30 tablets AA FDA listed
Folic Acid 1 mg 71610-0803-30 Aphena 30 tablets AA FDA listed
Folic Acid 1 mg 71610-0952-04 Aphena 4 tablets AA FDA listed
Folic Acid 1 mg 72162-1651-00 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 72162-2413-00 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 72162-2556-00 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 72162-2557-00 Bryant 1000 tablets AA FDA listed
Folic Acid 1 mg 72189-0199-30 DIRECT 30 tablets AA FDA listed
Folic Acid 1 mg 82804-0110-30 Proficient 30 tablets AA FDA listed
Folic Acid 1 mg 82868-0004-30 Northwind 30 tablets AA FDA listed
Folic Acid 1 mg 87441-0032-01 Unit 30 tablets AA FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Aug 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 11534-0165-03, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1M
Units reimbursed last 4 qtrs
43.4M
Gross reimbursed last 4 qtrs
$9.4M
Avg / prescription
$8.61
Avg / unit
$0.2167
Latest quarter Q4 2025
257.6KRx
Medicaid pays / ea
$0.2167
gross reimbursed
vs
NADAC / ea
$0.0194
acquisition cost
=
Spread
+$0.1973
+1017% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
57% FFS 43% MCO
Fee-for-service · 621,867 Rx Managed care · 470,019 Rx
State Medicaid map
Alaska: 59,009 units · 8,050 per 100k residents AK Maine: 273,928 units · 19,636 per 100k residents ME Washington: 741,391 units · 9,490 per 100k residents WA Idaho: 161,707 units · 8,234 per 100k residents ID Montana: 90,516 units · 7,996 per 100k residents MT North Dakota: 98,150 units · 12,535 per 100k residents ND Minnesota: 973,512 units · 16,969 per 100k residents MN Wisconsin: no data reported WI Michigan: 2,751,275 units · 27,411 per 100k residents MI New York: 6,457,815 units · 32,997 per 100k residents NY Vermont: 247,704 units · 38,285 per 100k residents VT New Hampshire: 99,226 units · 7,077 per 100k residents NH Oregon: 457,913 units · 10,818 per 100k residents OR Nevada: 249,256 units · 7,804 per 100k residents NV Wyoming: 16,198 units · 2,774 per 100k residents WY South Dakota: 39,169 units · 4,262 per 100k residents SD Iowa: 299,097 units · 9,326 per 100k residents IA Illinois: 2,464,164 units · 19,636 per 100k residents IL Indiana: 782,853 units · 11,409 per 100k residents IN Ohio: 1,881,057 units · 15,961 per 100k residents OH Pennsylvania: 1,693,076 units · 13,063 per 100k residents PA New Jersey: 1,051,779 units · 11,322 per 100k residents NJ Massachusetts: 992,049 units · 14,170 per 100k residents MA California: 8,787,911 units · 22,553 per 100k residents CA Utah: 119,297 units · 3,491 per 100k residents UT Colorado: 208,664 units · 3,550 per 100k residents CO Nebraska: no data reported NE Missouri: 655,718 units · 10,583 per 100k residents MO Kentucky: 1,650,538 units · 36,468 per 100k residents KY West Virginia: 507,599 units · 28,678 per 100k residents WV Virginia: 426,581 units · 4,894 per 100k residents VA Maryland: 642,037 units · 10,389 per 100k residents MD Connecticut: 572,562 units · 15,830 per 100k residents CT Rhode Island: 278,910 units · 25,471 per 100k residents RI Arizona: 527,869 units · 7,104 per 100k residents AZ New Mexico: 407,514 units · 19,277 per 100k residents NM Kansas: 198,226 units · 6,742 per 100k residents KS Arkansas: 296,702 units · 9,674 per 100k residents AR Tennessee: 412,214 units · 5,785 per 100k residents TN North Carolina: 414,476 units · 3,825 per 100k residents NC South Carolina: 271,206 units · 5,048 per 100k residents SC Delaware: 152,919 units · 14,832 per 100k residents DE Oklahoma: 459,026 units · 11,326 per 100k residents OK Louisiana: 819,057 units · 17,907 per 100k residents LA Mississippi: 229,388 units · 7,802 per 100k residents MS Alabama: 468,939 units · 9,180 per 100k residents AL Georgia: 500,044 units · 4,534 per 100k residents GA D.C.: 62,627 units · 9,223 per 100k residents DC Hawaii: 51,600 units · 3,596 per 100k residents HI Texas: 804,008 units · 2,636 per 100k residents TX Florida: 937,170 units · 4,145 per 100k residents FL
Units reimbursed · per 100k residents
2,63638,285
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 38,285 /100k
2 Kentucky 36,468 /100k
3 New York 32,997 /100k
4 West Virginia 28,678 /100k
5 Michigan 27,411 /100k
6 Rhode Island 25,471 /100k
7 California 22,553 /100k
8 Maine 19,636 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page11534-0165-03 1,091,886 Rx · $9,400,212
100 tablets11534-0165-01 78,717 Rx · $661,882
90 tablets11534-0165-90 No Medicaid data
Drug total (last 4 qtrs): 1,170,603 Rx · 47,173,184 units · $10,062,094 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Folic Acid — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Folic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$870.8K
Claims incl. refills
257.4K
Beneficiaries
188.1K
Spend / beneficiary
$4.63
Spend / claim
$3.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Folic Acid — the ingredient across all brands.

Top reported reactions

Fatigue24,048
Pain23,757
Arthralgia20,069
Rheumatoid Arthritis17,938
Nausea16,173
Diarrhoea14,763
Headache14,672

Age at onset

Neonate1,015
Infant160
Child541
Adolescent709
Adult22,906
Elderly14,367

Reporter sex

250,164 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Life-threatening14,703
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,312 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
11534-0165-01 100 TABLET in 1 BOTTLE (11534-165-01) $0.0194 / ea $1.94 2015-08-04 Active
11534-0165-03 You're viewing this 1000 TABLET in 1 BOTTLE (11534-165-03) $0.0194 / ea $19.35 2015-08-04 Active
11534-0165-90 90 TABLET in 1 BOTTLE (11534-165-90) 2017-09-29 Active

You're viewing the largest of 3 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0194 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 11534-0165-03?
NDC 11534-0165-03 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 11534-0165-03 and NDC 11534-0165-90?
Both are FOLIC ACID 1 mg Tablet — the drug itself is identical. NDC 11534-0165-03 is the 1,000-count package, while NDC 11534-0165-90 is the 90 tablets package.
What NDC number is used to bill for this package of FOLIC ACID 1 mg Tablet?
Bill NDC 11534-0165-03 — the 11-digit billing format is 11534016503. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 41 words

INDICATIONS AND USAGE Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

⏱️ Dosage and Administration 220 words

DOSAGE AND ADMINISTRATION Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid, USP given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation).

Doses greater than 0.1 mg should not be used unless anemia due to vitamin B 12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine. The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily.

Resistant cases may require larger doses. When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.

In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

Contraindications 16 words

CONTRAINDICATIONS Folic acid, USP is contraindicated in patients who have shown previous intolerance to the drug.

⚠️ Warnings 23 words

WARNINGS Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

🤒 Adverse Reactions 181 words

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm.

One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment.

Decreased vitamin B 12 serum levels may occur in patients receiving prolonged folic acid therapy. In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of folic acid daily.

🔄 Drug Interactions 111 words

Drug Interactions There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given. Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.

🤰 Pregnancy 94 words

Pregnancy Teratogenic Effects Pregnancy Category A Folic acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICATIONS AND USAGE ). Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if administered during pregnancy.

If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, folic acid should be used during pregnancy only if clearly needed.

🆘 Overdosage 96 words

OVERDOSAGE Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B 12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B 12 deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow. In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids.

Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption.

Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour. After intravenous administration, the drug is rapidly cleared from the plasma. Cerebrospinal fluid levels of folic acid are several times greater than serum levels of the drug.

Folic acid is metabolized in the liver to 7,8-dihydrofolic acid and eventually to 5,6,7,8-tetrahydrofolic acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases. Tetrahydrofolic acid is linked in the N 5 or N 10 positions with formyl, hydroxymethyl, methyl, or formimino groups. N 5 -formyltetrahydrofolic acid is leucovorin.

Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver. Normal serum levels of total folate have been reported to be 5 to 15 ng/mL; normal cerebrospinal fluid levels are approximately 16 to 21 ng/mL. Normal erythrocyte folate levels have been reported to range from 175 to 316 ng/mL.

In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia. After a single oral dose of 100 mcg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine.

After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces.

Folic acid is also excreted in the milk of lactating mothers.

📦 How Supplied / Storage and Handling 69 words

HOW SUPPLIED Folic Acid Tablets, USP 1 mg, are round, yellow tablets debossed “N8”on one side and bisected on other side and supplied in bottles of 90 (NDC 11534-165-90), 100 (NDC 11534-165-01) and 1000 (NDC 11534-165-03). Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured & Distributed by: Sunrise Pharmaceutical, Inc Rahway, NJ 07065 5357/01 Rev. September 2024

📋 Description 214 words

DESCRIPTION Folic acid, USP, N-[p-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino] benzoyl]-Lglutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para -aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid, USP are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid, USP is prepared synthetically.

Folic acid, USP occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid, USP is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid, USP (sodium folate). Aqueous solutions of folic acid, USP are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light.

The structural formula of folic acid, USP is as follows: C 19 H 19 N 7 O 6 M.W. 441.40 Each tablet, for oral administration, contains 1 mg folic acid, USP. Folic acid tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid.

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