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Bijuva estradiol and progesterone 1 mg; 100 mg Capsule, 5-count — NDC 68308-0750-00 package photo

Bijuva estradiol and progesterone 1 mg; 100 mg Capsule, 5-count

by Mayne Pharma · 1 BLISTER PACK in 1 CARTON (68308-750-00) / 5 CAPSULE in 1 BLISTER PACK
NDC 68308-0750-00
🏷️ FDA NDC (as labeled) 68308-750-00 billing pads the product segment with a zero
This package
Contains5-count Pack sizes2 compare ↓
Also priced by: Part D plans $8.06/unit — full pricing hub ↓
Also comes in: 30 capsules 68308-0750-30
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2027. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68308-750-00
Product NDC 68308-750
11-digit billing NDC 68308075000
RxCUI 2108924, 2108930, 2632844, 2632846
UNII 4TI98Z838E, 4G7DS2Q64Y
Application # NDA210132
SPL Set ID 59eadb88-c9f3-4871-b176-7ddd98faf9bc
Established class (EPC) Estrogen; Progesterone
Mechanism of action Estrogen Receptor Agonists
Chemical class Estradiol Congeners; Progesterone
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2023-12-18
Route ORAL
Dosage form CAPSULE
Substance ESTRADIOL; PROGESTERONE
GPI-14 24993002140120
GCN Seq No 079208
GCN 45661
HICL code 001417
Ingredient (HICL) Estradiol/Progesterone
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G1
Therapeutic class — intermediate (HIC2) Estrogens
HIC3 code G1F
Therapeutic class — specific (HIC3) Estrogen And Progestin Combinations
AHFS code 68:16.04.00
AHFS class Estrogens
FDB label name BIJUVA 1 MG-100 MG CAPSULE
FDB brand name Bijuva
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68308-750-00 — 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 → 68308-0750-00. 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 Radioactive Diagnostic Agent class.

Pharmacologic class Radioactive Diagnostic Agent, Estrogen
Drug family (ATC) Natural and semisynthetic estrogens, plain, Progestogens and estrogens, sequential preparations
How it works Positron Emitting Activity, Estrogen Receptor Agonists
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

LabelerMayne Pharma
Application holderMAYNE PHARMA LLC
FDA applicationNDA210132 (NDA)
Labeler code68308
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio29 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 BIJUVA 1 MG-100 MG CAPSULE Ingredient Estradiol/Progesterone
📖 What it is MedlinePlus · NLM

Estrogen and progestin are used to treat certain symptoms of menopause. Estrogen also prevents thinning of the bones (osteoporosis) in menopausal women. Estrogen and progestin are two female sex hormones. Hormone replacement therapy works by replacing estrogen hormone that is no longer being made by the body. Estrogen reduces feelings of warmth in the upper body and periods of sweating and heat (hot flashes), vaginal symptoms (itching, burning, and dryness) and difficulty with urination. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer in wome...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. If you still have your uterus, taking estrogen alone can cause the uterine lining to thicken too much over time, which raises the risk of uterine cancer. Progestero...
  • Why does my doctor want me on both estrogen and progesterone? Can't I just take estrogen?
  • Yes — both timing and food matter. Take your Bijuva capsule every evening, and always take it with food. Eating a meal significantly increases how much progesterone your body actua...
  • Does it matter when I take Bijuva, and do I really need food?
📖 Read our full Estradiol / Progesterone guide →

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.

💊 What it looks like

Color pink
ShapeCapsule
Imprint5C1
Size15 mm
ScoringNot scored
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 76845O8NMZ
    Ethyl acetate is a clear, colorless liquid solvent derived from acetic acid and ethanol. In medicines, it dissolves active ingredients, carries them into the product formulation, and helps control how quickly the drug releases and works in your body.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII A7JR5F8DLH
    Gelatin Type B is a protein derived from animal bones and connective tissue. In medicines, it forms capsule shells that hold and protect the active drug, and may also act as a binder to help tablets hold together.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII U72Q2I8C85
    A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
  • UNII H5ZC52369M
    A synthetic ingredient made from plant-based lauric acid and polyethylene glycol. It acts as a solubilizer and emulsifier to help dissolve and blend oil and water components in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 58QVG85GW3
    A synthetic polymer made from vinyl acetate and phthalic acid. It coats tablets and capsules to control when and where the medicine dissolves in the digestive system, protecting the contents from stomach acid.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

15 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.

💲 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 · Q2 2026 $8.06 $40.29 / 5 capsules
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
Bijuva 1 mg/1; 100 mg 50261-0211-05 Mayne 5 capsules — — Discontinued —
Bijuva 1 mg/1; 100 mgthis 68308-0750-00 Mayne 5 capsules — — Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2018
First FDA approval
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 28, 2018 RLD RS ⏳ ~6.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10206932 — method of use (U-2439)
US 8846649 — method of use (U-2439)
US 8846648 — method of use (U-2439)
US 9114146 — method of use (U-2439)
US 9114145 — method of use (U-2439)
US 10675288 — method of use (U-2439)
US 9301920 — method of use (U-2439)
US 11033626 — method of use (U-2439)
US 9006222 — method of use (U-2439)
US 10806740 — method of use (U-2439)
US 11103513 — method of use (U-2439)
US 11793819 — method of use (U-2439)
US 11793819 — method of use (U-2439)
US 11033626 — method of use (U-2439)
US 10206932 — method of use (U-2439)
US 9301920 — method of use (U-2439)
US 9114146 — method of use (U-2439)
US 9114145 — method of use (U-2439)
US 8933059 — method of use (U-2439)
US 8846649 — method of use (U-2439)
US 8846648 — method of use (U-2439)
US 10675288 — method of use (U-2439)
US 8993548 — drug product
US 8987237 — drug product
US 8987237 — drug product
US 11166963 — drug product
US 8993549 — drug product
US 11529360 — drug product
US 8993549 — drug product
US 8633178 — drug product
US 10639375 — drug product
US 8633178 — drug product
US 10052386 — drug product
US 10052386 — drug product
US 11865179 — drug substance
US 11865179 — drug substance
US 11110099 — drug product
US 11103516 — drug product
US 8993548 — drug product
2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (39)
PatentTypeUse codeExpires
US 10206932 ↗ Method of use U-2439 Nov 21, 2032
US 8846649 ↗ Method of use U-2439 Nov 21, 2032
US 8846648 ↗ Method of use U-2439 Nov 21, 2032
US 9114146 ↗ Method of use U-2439 Nov 21, 2032
US 9114145 ↗ Method of use U-2439 Nov 21, 2032
US 10675288 ↗ Method of use U-2439 Nov 21, 2032
US 9301920 ↗ Method of use U-2439 Nov 21, 2032
US 11033626 ↗ Method of use U-2439 Nov 21, 2032
US 9006222 ↗ Method of use U-2439 Nov 21, 2032
US 10806740 ↗ Method of use U-2439 Nov 21, 2032
US 11103513 ↗ Method of use U-2439 Nov 21, 2032
US 11793819 ↗ Method of use U-2439 Nov 21, 2032
US 11793819 ↗ Method of use U-2439 Nov 21, 2032
US 11033626 ↗ Method of use U-2439 Nov 21, 2032
US 10206932 ↗ Method of use U-2439 Nov 21, 2032
US 9301920 ↗ Method of use U-2439 Nov 21, 2032
US 9114146 ↗ Method of use U-2439 Nov 21, 2032
US 9114145 ↗ Method of use U-2439 Nov 21, 2032
US 8933059 ↗ Method of use U-2439 Nov 21, 2032
US 8846649 ↗ Method of use U-2439 Nov 21, 2032
US 8846648 ↗ Method of use U-2439 Nov 21, 2032
US 10675288 ↗ Method of use U-2439 Nov 21, 2032
US 8993548 ↗ Drug product — Nov 21, 2032
US 8987237 ↗ Drug product — Nov 21, 2032
US 8987237 ↗ Drug product — Nov 21, 2032
US 11166963 ↗ Drug product — Nov 21, 2032
US 8993549 ↗ Drug product — Nov 21, 2032
US 11529360 ↗ Drug product — Nov 21, 2032
US 8993549 ↗ Drug product — Nov 21, 2032
US 8633178 ↗ Drug product — Nov 21, 2032
US 10639375 ↗ Drug product — Nov 21, 2032
US 8633178 ↗ Drug product — Nov 21, 2032
US 10052386 ↗ Drug product — Nov 21, 2032
US 10052386 ↗ Drug product — Nov 21, 2032
US 11865179 ↗ Drug substance — Nov 21, 2032
US 11865179 ↗ Drug substance — Nov 21, 2032
US 11110099 ↗ Drug product — Nov 21, 2032
US 11103516 ↗ Drug product — Nov 21, 2032
US 8993548 ↗ Drug product — Nov 21, 2032
Common questions
Is there a generic version of BIJUVA 1 MG-100 MG CAPSULE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BIJUVA 1 MG-100 MG CAPSULE. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 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.
30 capsules68308-0750-30 1,204 Rx · $448,848
5 capsules this page68308-0750-00 No Medicaid data
Drug total (last 4 qtrs): 1,204 Rx · 54,060 units · $448,848 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 Bijuva — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Bijuva. 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
$244.6K
Claims incl. refills
582
Beneficiaries
397
Spend / beneficiary
$616.08
Spend / claim
$420.25
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
68308-0750-00 You're viewing this 1 BLISTER PACK in 1 CARTON (68308-750-00) / 5 CAPSULE in 1 BLISTER PACK — — 2023-12-18 Inactivated by FDA
68308-0750-30 1 BLISTER PACK in 1 CARTON (68308-750-30) / 30 CAPSULE in 1 BLISTER PACK $8.53 / ea $255.95 2023-12-18 Inactivated by FDA

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 68308-0750-00?
NDC 68308-0750-00 is a 5-count package — 1 blister pack in 1 carton / 5 capsule in 1 blister pack.
What is the difference between NDC 68308-0750-00 and NDC 68308-0750-30?
Both are Bijuva estradiol and progesterone 1 mg; 100 mg Capsule — the drug itself is identical. NDC 68308-0750-00 is the 5-count package, while NDC 68308-0750-30 is the 30 capsules package.
What NDC number is used to bill for this package of Bijuva estradiol and progesterone 1 mg; 100 mg Capsule?
Bill NDC 68308-0750-00 — the 11-digit billing format is 68308075000. 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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 ✓ Available
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 68308-750-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68308-0750-00, written without dashes as 68308075000. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68308-0750-00, the first segment (68308) is the labeler code FDA assigned to Mayne Pharma; the middle segment (0750) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (68308-0750-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1.1 )

1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause

⏱️ Dosage and Administration 103 words ▾

2 DOSAGE AND ADMINISTRATION The timing of BIJUVA initiation can affect the overall risk-benefit profile. Consider initiating BIJUVA in women < 60 years old or < 10 years from onset of menopause [see Warnings and Precautions (5) , Adverse Reactions (6.1) , Use in Specific Populations (8.5) and Clinical Studies (14) ] . Take a single BIJUVA capsule orally each evening with food.

Generally, start therapy with BIJUVA 0.5 mg estradiol/100 mg progesterone dosage strength. Make dosage adjustment based on the clinical response. Attempt to taper or discontinue BIJUVA at 3 to 6 month intervals.

One capsule orally each evening with food. (2.1)

💊 Dosage Forms and Strengths 74 words ▾

3 DOSAGE FORMS AND STRENGTHS BIJUVA capsules, 0.5 mg/100 mg, are oval shaped, opaque, light pink on one side, dark pink on the other side, and printed with "5C1" in white ink. BIJUVA capsules, 1 mg/100 mg, are oval shaped, opaque, light pink on one side, dark pink on the other side, and printed with "1C1" in white ink. Capsules: 0.5 mg estradiol/100 mg progesterone or 1 mg estradiol/100 mg progesterone. ( 3 )

⛔ Contraindications 217 words ▾

4 CONTRAINDICATIONS BIJUVA is contraindicated in women with any of the following conditions: Abnormal genital bleeding of unknown etiology [see Warnings and Precautions (5.2) ]. Breast cancer or a history of breast cancer [see Warnings and Precautions (5.2) ]. Estrogen-dependent neoplasia [see Warnings and Precautions (5.2) ].

Active deep vein thrombosis (DVT), pulmonary embolisum (PE), or history of these conditions [see Warnings and Precautions (5.1) ]. Active arterial thromboembolic disease (for example, stroke, myocardial infarction (MI)), or a history of these conditions [see Warnings and Precautions (5.1) ]. Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA.

Hepatic impairment or disease [see Warnings and Precautions (5.8) ] Known thrombophilic disorders, such as protein C, protein S, or antithrombin deficiency Undiagnosed abnormal genital bleeding ( 4 , 5.2 ) Breast cancer or a history of breast cancer ( 4 , 5.2 ) Estrogen-dependent neoplasia ( 4 , 5.2 ) Active DVT, PE, or history of these conditions ( 4 , 5.1 ) Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4 , 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA ( 4 , 5.15 ) Hepatic impairment or disease ( 4 , 5.8 ) Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders: Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy. Manage risk factors for arterial vascular disease and/or venous thromboembolisum. Discontinue if an arterial or venous thrombotic or thromboembolic event occurs.

( 5.1 ) Malignant Neoplasms: Assess risk and provide surveillance measures for breast cancer, such as breast examinations and mammography. ( 5.2 ) Estrogens increase the risk of gallbladder disease. ( 5.3 ) Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.

( 5.4 , 5.5 , 5.7 , 5.8 ) Monitor thyroid function in women on thyroid replacement hormone therapy. ( 5.9 , 5.15 )

5.1Cardiovascular Disorders BIJUVA is contraindicated in females with active DVT, PE, arterial thromboembolic disease (e.g., stroke, MI) disease, or a history of these conditions [see Contraindications (4) ] . Immediately discontinue BIJUVA if a PE, DVT, stroke, or MI occurs or is suspected. If feasible, discontinue BIJUVA at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.

The safety and efficacy of BIJUVA for the prevention of cardiovascular disorders has not been established [see Clinical Studies (14.4) ] . The Women's Health Initiative (WHI) estrogen plus progestin trial reported increased risks of PE, DVT, stroke, and MI in postmenopausal women (50 to 79 years of age, average age 63.4 years) during the 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. Analyses were also conducted in women aged 50-59 years, a group of women more likely to present with new onset of moderate to severe VMS compared to women in other age groups in the trial [see Clinical Studies (14.4) ] .

Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin trial of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Venous Thromboembolism In women aged 50-59 years, the WHI estrogen plus progestin trial reported a relative risk for PE of 2.05 (95% confidence interval [CI], 0.89-4.71) for CE/MPA compared to placebo, with a risk difference of 6 per 10,000 women-years (WYs; 11 versus 5). The relative risk for DVT was 3.01 (95% CI, 1.36-6.66) in those receiving CE/MPA compared to placebo, with a risk difference of 10 per 10,000 WYs (15 versus 5) [see Clinical Studies (14.4) ] . In the overall study population of women aged 50-79 years (average 63.4 years), the trial reported a relative risk for PE of 1.98 (95% CI, 1.36-2.87) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (18 versus 9).

The relative risk for DVT was 1.87 (95% CI, 1.37-2.54) for CE/MPA compared to placebo, with a risk difference of 12 per 10,000 WYs (25 versus 14) [see Clinical Studies (14.4) ] . Stroke In women aged 50-59 years, the WHI estrogen plus progestin trial reported a relative risk for stroke of 1.51 (95% CI, 0.81-2.82) for CE/MPA compared to placebo, with a risk difference of 5 per 10,000 WYs (15 versus 10) [see Clinical Studies (14.4) ] . In the overall study population of women aged 50-79 years (average 63.4 years), the WHI estrogen plus progestin trial reported relative risk for stroke of 1.37 (95% CI, 1.07-1.76) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (33 versus 24) [see Clinical Studies (14.4) ] .

Coronary Heart Disease In women 50 to 59 years of age, the WHI estrogen plus progestin trial reported a relative risk for coronary heart disease (CHD) events (d…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1) ]. Malignant Neoplasms [see Warnings and Precautions (5.2) ]. The most common adverse reactions with BIJUVA (incidence ≥ 3% of women and greater than placebo) are: breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge and pelvic pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharmaat 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of estradiol and progesterone capsules was assessed in a 1-year trial that included 1,835 postmenopausal women (1,684 were treated with estradiol and progesterone capsules once daily and 151 women received placebo).

Most women (~70%) in the active treatment groups were treated for ≥ 326 days. Treatment related adverse reactions with an incidence of ≥ 3% in either BIJUVA (estradiol and progesterone) capsules group and numerically greater than those reported in the placebo group are listed in Table 1. Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 3% and Numerically More Common in Women Receiving BIJUVA (estradiol and progesterone) 0.5 mg/100 mg and 1 mg/100 mg Preferred Term BIJUVA 0.5 mg/100 mg BIJUVA 1 mg/100 mg Placebo (N=151) (N=424) (N=415) Breast tenderness 17 (4.0) 43 (10.4) 1 (0.7) Headache 17 (4.0) 14 (3.4) 1 (0.7) Nausea 15 (3.5) 9 (2.2) 1 (0.7) Vaginal bleeding 10 (2.4) 14 (3.4) 0 Vaginal discharge 8 (1.9) 14 (3.4) 1 (0.7) Pelvic pain 12 (2.8) 13 (3.1) 0

6.2Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of BIJUVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders Abdominal pain and discomfort, abdominal distention, diarrhea, nausea, vomiting.

General disorders and administration site conditions Fatigue, feeling abnormal, malaise. Investigations Weight increased. Metabolism and nutrition disorders Fluid retention.

Musculoskeletal and connective tissue disorders Muscle spasms, pain in extremity. Nervous system disorders Dizziness, headache, somnolence. Psychiatric disorders Insomnia, sleep disorder.

Reproductive system and breast disorders Breast pain, breast tenderness, uterine bleeding. Skin and subcutaneous tissue disorders Night sweats, pruritus. Vascular disorders Hot flush.

🔄 Drug Interactions 124 words ▾

7 DRUG INTERACTIONS In-vitro and in-vivo studies have shown that estrogens and progestins are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism. Inducers of CYP3A4 such as St.

John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of the estrogen or the progestin or both and may result in adverse reactions. Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration.

( 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary BIJUVA is not indicated for use in pregnancy. There are no data with the use of BIJUVA in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary Estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BIJUVA and any potential adverse effects on the breastfed child from BIJUVA or from the underlying maternal condition.

8.4Pediatric Use BIJUVA is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

8.5Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing BIJUVA to determine whether those over 65 years of age differ from younger women in their response to BIJUVA. The Women's Health Initiative Studies In the WHI estrogen plus progestin trial (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.4) ] . The Women's Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin [see Clinical Studies (14.5) ] .

It is unknown whether these findings apply to younger postmenopausal women [see Clinical Studies (14.5) ] . The safety and efficacy of BIJUVA for the prevention of dementia has not been established.

🤰 Pregnancy 90 words ▾

8.1Pregnancy Risk Summary BIJUVA is not indicated for use in pregnancy. There are no data with the use of BIJUVA in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use BIJUVA is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

🧓 Geriatric Use 158 words ▾

8.5Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing BIJUVA to determine whether those over 65 years of age differ from younger women in their response to BIJUVA. The Women's Health Initiative Studies In the WHI estrogen plus progestin trial (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.4) ] . The Women's Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin [see Clinical Studies (14.5) ] .

It is unknown whether these findings apply to younger postmenopausal women [see Clinical Studies (14.5) ] . The safety and efficacy of BIJUVA for the prevention of dementia has not been established.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE Overdosage of estrogen plus progestogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of BIJUVA therapy with institution of appropriate symptomatic care.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.

After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.

To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism.

Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Endogenous progesterone is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium.

Progesterone enhances cellular differentiation and generally opposes the actions of estrogens by decreasing estrogen receptor levels, increasing local metabolism of estrogens to less active metabolites, or inducing gene products that blunt cellular responses to estrogen. Progesterone exerts its effects in target cells by binding to specific progesterone receptors that interact with progesterone response elements in target genes. Progesterone receptors have been identified in the female reproductive tract, breast, pituitary, hypothalamus, and central nervous system.

12.2Pharmacodynamics Generally, a serum estrogen concentration does not predict an individual woman's therapeutic response to BIJUVA nor her risk for adverse outcomes. Likewise, exposure comparisons across different estrogen products to infer efficacy or safety for the individual woman may not be valid.

12.3Pharmacokinetics Absorption The oral absorption of both estradiol and progesterone is subject to first-pass metabolism. After multiple doses of BIJUVA (estradiol and progesterone) capsules administered with food, the t max (the time at which the maximum concentration is attained) for estradiol is approximately 3 to 6 hours and approximately 3 hours for progesterone (Figure 1, Figure 2, and Table 2, below). Steady state for both estradiol and progesterone components of BIJUVA, as well as estradiol's main metabolite, estrone, is achieved within seven days.

A dose-dependent increase in AUC 0-t and C max of estradiol and a slightly more than proportionality increase in AUC 0-t and C max of estrone were observed when the dose of estradiol was increased from 0.5 mg/day to 1 mg/day (Table 2). Figure 1: Mean Steady-State Serum Estradiol Concentrations Following Daily Oral Administration of 0.5 mg Estradiol/100 mg Progesterone or 1 mg Estradiol/100 mg Progesterone with Food (Baseline Adjusted, at Day 7) Figure 2: Mean Steady-State Serum Progesterone Concentrations Following Daily Oral Administration of 0.5 mg Estradiol/100 mg Progesterone or 1 mg Estradiol/100 mg Progesterone with Food (Baseline Adjusted, at Day 7) Table 2: Mean (SD) Steady-State Pharmacokinetic Parameters after Administration of Capsules Containing 0.5 mg Estradiol/100 mg Progesterone or 1 mg Estradiol/100 mg Progesterone with Food in Healthy Postmenopausal Women (Baseline Adjusted, at Day 7) Dosage Strength (estradiol/progesterone) BIJUVA 0.5 mg/100 mg Mean (SD) BIJUVA 1 mg/100…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.

After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.

To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism.

Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Endogenous progesterone is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium.

Progesterone enhances cellular differentiation and generally opposes the actions of estrogens by decreasing estrogen receptor levels, increasing local metabolism of estrogens to less active metabolites, or inducing gene products that blunt cellular responses to estrogen. Progesterone exerts its effects in target cells by binding to specific progesterone receptors that interact with progesterone response elements in target genes. Progesterone receptors have been identified in the female reproductive tract, breast, pituitary, hypothalamus, and central nervous system.

📦 How Supplied / Storage and Handling 174 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, are oval-shaped opaque capsules, which are light pink on one side and dark pink on the other side. Each capsule is imprinted in white ink indicating the dosage strength (5C1). BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, are provided in a blister package of 30 capsules.

BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg, are oval-shaped opaque capsules, which are light pink on one side and dark pink on the other side. Each capsule is imprinted in white ink indicating the dosage strength (1C1). BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg, are provided in a blister package of 30 capsules.

BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg NDC 68308-751-30 BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg NDC 68308-750-30 Keep out of reach of children. Packages are not child-resistant.

16.2Storage and Handling Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]

📦 Storage and Handling 26 words ▾

16.2Storage and Handling Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]

📋 Description 188 words ▾

11 DESCRIPTION BIJUVA (estradiol and progesterone) is an oval shaped opaque capsule in which the estradiol is solubilized and the progesterone is micronized and suspended in the mixture of medium chain mono and di-glycerides and lauroyl polyoxyl-32 glycerides. Each 0.5 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "5C1" in white ink. Each 1 mg/100 mg capsule is light pink on one side, dark pink on the other side, and printed with "1C1" in white ink.

Estradiol (estra-1,3,5 (10)-triene-3,17β-diol), an estrogen, has a molecular weight of 272.38, and chemical formula C 18 H 24 O 2 . Progesterone (pregn-4-ene-3, 20-dione) has a molecular weight of 314.47, and chemical formula C 21 H 30 O 2 . The structural formulas are as follows: Estradiol Progesterone Each BIJUVA (estradiol and progesterone) capsule contains the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di- glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide.

Chemical Structure Chemical Structure

💬 Information for Patients 157 words ▾

17 PATIENT COUNSELING INFORMATION Advise women to read the FDA-approved patient labeling (Patient Information). Vaginal Bleeding Inform postmenopausal women to report any vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.2) ]. Possible Serious Adverse Reactions with Estrogen Plus Progestogen Therapy Inform postmenopausal women of possible serious adverse reactions of estrogen plus progestogen therapy including cardiovascular disorders and malignant neoplasms [see Warnings and Precautions (5.1 , 5.2 )] .

Possible Common Adverse Reactions with Estrogen Plus Progestogen Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen plus progestogen therapy such as breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge, and pelvic pain [see Adverse Reactions (6.1) ] . Missed Evening Dose of BIJUVA Advise the woman that if she misses her evening dose, she should take the dose with food as soon as she can, unless it is within two hours of the next evening dose.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68308-0748-00 · Mayne 68308-0751-00 · Mayne →
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.