ALTAVERA Levonorgestrel and Ethinyl Estradiol Kit
by Bryant Ranch Prepack · 3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
NDC 63629-2343-01
🏷️ FDA NDC (as labeled)
63629-2343-1
billing pads the package segment with a zero
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)
63629-2343-1
Product NDC
63629-2343
11-digit billing NDC
63629234301
NCPDP billing unit
EA — each (per item)
Application #
ANDA079102
SPL Set ID
c607816d-0da9-4960-9723-69f28aa3f2f2
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2018-01-01
Dosage form
KIT
GPI-14
25990002400310
GPI class
Levonorgestrel-Ethinyl Estrad
GCN Seq No
003314
GCN
11530
HICL code
001460
Ingredient (HICL)
Levonorgestrel/Ethin.estradiol
HIC1 code
G
Therapeutic class — broad (HIC1)
Female Genital System
HIC2 code
G8
Therapeutic class — intermediate (HIC2)
Systemic Antifertility Agents
HIC3 code
G8A
Therapeutic class — specific (HIC3)
Contraceptives,Oral
AHFS code
68:12.00.00
AHFS class
Contraceptives
FDB label name
LEVONOR-ETH ESTRAD 0.15-0.03
FDB brand name
Levonorgestrel-Eth Estradiol
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 63629-2343-1 — a 5-4-1 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 package segment → 63629-2343-01. 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 Estrogen class.
Pharmacologic class
Estrogen
Drug family (ATC)
Progestogens and estrogens, sequential preparations, Natural and semisynthetic estrogens, plain, Estrogens
How it works
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
LabelerBryant Ranch Prepack
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA079102 (ANDA)
Labeler code63629
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio4,434 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 LEVONOR-ETH ESTRAD 0.15-0.03 Ingredient Levonorgestrel/Ethin.estradiol
📖 What it is MedlinePlus · NLM
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and levonorgestrel (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It prevents pregnancy mainly by stopping your ovaries from releasing an egg. It also thickens the cervical mucus so sperm can't easily get through, and changes the uterine lining a...
- What exactly does this medication do, and how well does it work?
- The most common ones in the first few months are headaches, nausea, irregular bleeding or spotting, breast tenderness, and mood changes. Most of these tend to settle down after you...
- Are there any side effects I should expect when I first start?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Levonorgestrel and Ethinyl Estradiol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Brown / White
ShapeRound
ImprintSZ;J1
Size6 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.
A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 system | Per each | Per 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 | $0.1851 | $0.56 / 3 kit |
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Altavera 70700-0116-85 | Xiromed, | 1 kit | $0.113 | AB | Availability likely | — |
| Ayuna 65862-0848-88 | Aurobindo | 3 pouches | $0.113 | AB | Availability likely | — |
| Levonorgestrel And Ethinyl Estradiol 00378-6550-53 | Mylan | 3 pouches | $0.113 | AB | Discontinued | — |
| Chateal EQ 50102-0230-23 | Afaxys | 3 pouches | $0.113 | AB | Availability likely | — |
| Marlissa 68462-0388-29 | Glenmark | 1 kit | $0.113 | AB | Availability likely | — |
| Kurvelo 68180-0844-73 | Lupin | 63 tablets | $0.113 | AB | Availability likely | — |
| Portia 00555-9020-58 | Teva | 6 pouches | $0.113 | — | Availability likely | — |
| Daysee 68180-0846-13 | Lupin | 2 pouches | $0.125 | AB | Availability likely | — |
| Levora 51862-0097-06 | Mayne | 1 kit | $0.145 | AB | Discontinued | — |
| Lessina 00555-9014-67 | Teva | 3 pouches | $0.151 | — | Availability likely | — |
| Aubra EQ 50102-0220-23 | Afaxys | 3 pouches | $0.151 | AB1 | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0854-73 | Lupin | 1 kit | $0.151 | AB1 | Availability likely | — |
| Levonorgestrel And Ethinyl Estradiol 00378-7287-53 | Mylan | 3 pouches | $0.151 | AB1 | Availability likely | — |
| Aviane 00555-9045-58 | Teva | 6 pouches | $0.151 | — | Availability likely | — |
| Vienva 70700-0118-85 | Xiromed, | 1 kit | $0.151 | AB1 | Availability likely | — |
| Falmina 16714-0359-01 | Northstar | 1 packet | $0.151 | AB1 | Availability likely | — |
| Lutera 51862-0028-06 | Mayne | 1 kit | $0.152 | AB1 | Discontinued | — |
| Sronyx 51862-0545-06 | Mayne | 1 kit | $0.174 | AB2 | Discontinued | — |
| Introvale 70700-0117-87 | Xiromed, | 1 kit | $0.184 | AB | FDA listed | — |
| Setlakin 16714-0366-03 | Northstar | 3 pouches | $0.221 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0843-13 | Lupin | 1 kit | $0.221 | AB | Availability likely | — |
| levonorgestrel and ethinyl estradiol 68462-0672-95 | Glenmark | 3 pouches | $0.221 | AB | Availability likely | — |
| Afirmelle 65862-0849-88 | Aurobindo | 3 pouches | $0.225 | AB1 | FDA listed | — |
| Iclevia 65862-0865-83 | Aurobindo | 3 pouches | $0.227 | AB | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 | Lupin | 2 pouches | $0.239 | AB | Availability likely | — |
| Levonest 16714-0340-01 | Northstar | 1 packet | $0.339 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0857-73 | Lupin | 1 kit | $0.339 | AB | Availability likely | — |
| Tyblume 00642-7471-01 | Exeltis | 1 kit | $0.828 | — | Availability likely | — |
| levonorgestrel and ethinyl estradiol 42192-0623-03 | Acella | 1 kit | $3.442 | AB3 | Availability likely | — |
| Levonest 50090-2505-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Kurvelo 50090-6374-00 | A-S | 21 tablets | — | AB | FDA listed | — |
| Altaverathis 63629-2343-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Lutera 55741-0005-06 | Dr. | 1 kit | — | AB1 | FDA listed | — |
| Balcoltra 75854-0602-02 | Avion | 1 kit | — | AB3 | FDA listed | — |
| Vienva Tm 50090-5580-00 | A-S | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0003-07 | Naari | 1 kit | — | AB | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4898-08 | Apotex | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4899-08 | Apotex | 1 kit | — | AB | FDA listed | — |
| Vienva TM 63629-2344-01 | Bryant | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0004-07 | Naari | 1 kit | — | AB1 | FDA listed | — |
| Aviane 63187-0889-28 | Proficient | 1 pouch | — | — | 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
🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Altavera — 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 Altavera. 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
$22.1K
Claims incl. refills
936
Beneficiaries
600
Spend / beneficiary
$36.84
Spend / claim
$23.61
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-2343-01 You're viewing this | 3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2018-01-01 | Active |
🧭 About this NDC listing & data coverage
Finished prescription product
Kit / multi-component package
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
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 63629-2343-1, 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: 63629-2343-01, written without dashes as 63629234301. 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 63629-2343-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2343) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
📄 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.
🚨 Boxed Warning
🎯 Indications and Usage
🧬 Clinical Pharmacology
📦 How Supplied / Storage and Handling
📋 Description
🚨 Boxed Warning ▾
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Altavera, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Altavera is indicated for use by females of reproductive potential to prevent pregnancy.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED/STORAGE AND HANDLING Altavera tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/30 mcg) are available in packages of 3 compact dispensers, each containing 28 tablets: 21 Active Tablets: Peach, round, unscored, debossed with SZon one side and J4on the other side. 7 Inert Tablets: White, round, unscored, debossed with SZon one side and J1on the other side. 3 individual blisters NDC 63629-2343-1 Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.
Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.