ALTAVERA Levonorgestrel and Ethinyl Estradiol Kit — NDC 63629-2343-1 (Billing 63629-2343-01)
This is a package of ALTAVERA Levonorgestrel and Ethinyl Estradiol Kit from Bryant Ranch Prepack, marketed since Jan 2018 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 63629-2343-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63629 labeler · 2343 product · 1 package
- Package marketed since
- Jan 1, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6362923431 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003314
- GCN: 11530
- GPI-14 (Medi-Span): 25990002400310
- HICL (First Databank): 001460
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 238019
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Estrogen class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It prevents pregnancy. It is a combined hormonal birth control with an estrogen and a progestin. It comes as daily tablets or as the weekly Twirla patch.
- With tablets, you take one at the same time every day, no more than 24 hours apart. With the Twirla patch, you wear one patch for a week, three weeks in a row, then take a patch-fr...
- Headache, nausea, acne, breast tenderness, mood changes, and irregular bleeding are the common ones. Bleeding changes often settle with time. Call your doctor if they persist.
- Get help for chest pain, sudden shortness of breath, leg swelling or pain, vision loss, or severe new headaches. These can signal a blood clot or stroke. Also report yellowing of y...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63629-2343-01 You're viewing this Main listing | 3 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2018-01-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levonorgestrel And Ethinyl Estradiol 00378-6550-53 | Mylan | 3 pouches | $0.113 | AB | Discontinued | — |
| Altavera 70700-0116-85 | Xiromed, | 1 kit | $0.114 | AB | Availability likely | — |
| Ayuna 65862-0848-88 | Aurobindo | 3 pouches | $0.114 | AB | Availability likely | — |
| Chateal EQ 50102-0230-23 | Afaxys | 3 pouches | $0.114 | AB | Availability likely | — |
| Marlissa 68462-0388-29 | Glenmark | 1 kit | $0.114 | AB | Availability likely | — |
| Kurvelo 68180-0844-73 | Lupin | 63 tablets | $0.114 | AB | Availability likely | — |
| Portia 00555-9020-58 | Teva | 6 pouches | $0.114 | — | 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 | — |
| Levonorgestrel And Ethinyl Estradiol 00378-7287-53 | Mylan | 3 pouches | $0.151 | AB1 | Availability likely | — |
| Lutera 51862-0028-06 | Mayne | 1 kit | $0.152 | AB1 | Discontinued | — |
| Lessina 00555-9014-67 | Teva | 3 pouches | $0.154 | — | Availability likely | — |
| Aubra EQ 50102-0220-23 | Afaxys | 3 pouches | $0.154 | AB1 | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0854-73 | Lupin | 1 kit | $0.154 | AB1 | Availability likely | — |
| Aviane 00555-9045-58 | Teva | 6 pouches | $0.154 | — | Availability likely | — |
| Vienva 70700-0118-85 | Xiromed, | 1 kit | $0.154 | AB1 | Availability likely | — |
| Falmina 16714-0359-01 | Northstar | 1 packet | $0.154 | AB1 | Availability likely | — |
| Sronyx 51862-0545-06 | Mayne | 1 kit | $0.174 | AB2 | Discontinued | — |
| Introvale 70700-0117-87 | Xiromed, | 1 kit | $0.184 | AB | FDA listed | — |
| Afirmelle 65862-0849-88 | Aurobindo | 3 pouches | $0.225 | AB1 | FDA listed | — |
| Iclevia 65862-0865-83 | Aurobindo | 3 pouches | $0.227 | AB | FDA listed | — |
| Setlakin 16714-0366-03 | Northstar | 3 pouches | $0.227 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0843-13 | Lupin | 1 kit | $0.227 | AB | Availability likely | — |
| levonorgestrel and ethinyl estradiol 68462-0672-95 | Glenmark | 3 pouches | $0.227 | AB | Availability likely | — |
| 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 | $0.324 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0857-73 | Lupin | 1 kit | $0.324 | AB | Availability likely | — |
| Tyblume 00642-7471-01 | Exeltis | 1 kit | $0.828 | — | Availability likely | — |
| levonorgestrel and ethinyl estradiol 42192-0623-03 | Acella | 1 kit | $3.445 | 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Ethinyl Estradiol / Levonorgestrel inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Bryant Ranch Prepack labeler code 63629
- Fluocinonide .05 mg/g Ointment NDC 63629-2337-1
- Fluocinonide .05 mg/g Ointment NDC 63629-2338-1
- Fluocinonide .05 mg/g Ointment NDC 63629-2339-1
- Lansoprazole 30 mg Capsule, Delayed Release NDC 63629-2340-1
- Lansoprazole 30 mg Capsule, Delayed Release NDC 63629-2341-1
- Lansoprazole 30 mg Capsule, Delayed Release NDC 63629-2342-1
- Vienva TM Levonorgestrel and Ethinyl Estradiol Kit NDC 63629-2344-1
- JAIMIESS levonorgestrel / ethinyl estradiol and Kit NDC 63629-2345-1
- Midodrine Hydrochloride 10 mg Tablet NDC 63629-2346-1
- Midodrine Hydrochloride 5 mg Tablet NDC 63629-2347-1
- Midodrine Hydrochloride 2.5 mg Tablet NDC 63629-2348-1
- Estarylla Norgestimate and ethinyl estradiol Kit NDC 63629-2349-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 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.
📄 Patient Package Insert ▾
Patient Information ALTAVERA [ all-tuh-VAIR-u h] (levonorgestrel 0.15 mg and ethinyl estradiol 30 mcg tablets) What is the most important information I should know about Altavera? Do not use Altavera if you smoke cigarettes and are over 35 years old. S moking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke.
This risk increases with age and the number of cigarettes you smoke. What is Altavera? Altavera is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does Altavera work for contraception? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use Altavera. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness.
The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Who should not take Altavera?
Do not take Altavera if you: • smoke and are over 35 years of age • had blood clots in your arms, legs, lungs, or eyes • had a problem with your blood that makes it clot more than normal • have certain heart valve problems or irregular heart beat • had a stroke • had a heart attack • have high blood pressure that cannot be controlled by medicine • have diabetes with kidney, eye, nerve, or blood vessel damage • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age • had breast cancer or any cancer that is sensitive to female hormones • have liver problems, including liver tumors • have any unexplained vaginal bleeding • are pregnant • take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. If any of these conditions happen while you are taking Altavera, stop taking Altavera right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Altavera.
What should I tell my healthcare provider before taking Altavera? Tell your healthcare provider if you: • are pregnant or think you may be pregnant • are depressed now or have been depressed in the past • had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) • are breastfeeding or plan to breastfeed. Altavera may decrease the amount of breast milk you make.
A small amount of the hormones in Altavera may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Altavera may affect the way other medicines work, and other medicines may affect how well Altavera works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Altavera? Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of Altavera? • Like pregnancy, Altavera may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death.
Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions For Use ALTAVERA [all-tuh-VAIR-uh] (levonorgestrel 0.15 mg and ethinyl estradiol tablets 30 mcg) Important Information about taking Altavera • Take 1 pill every day at the same time. Take the pills in the order directed on your pill pack. • Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant.
The more pills you miss, the more likely you are to get pregnant. • If you have trouble remembering to take Altavera, talk to your healthcare provider. • When you first start taking Altavera, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. • You may feel sick to your stomach (nauseous), especially during the first few months of taking Altavera. If you feel sick to your stomach, do not stop taking the pill.
The problem will usually go away. If your nausea does not go away, call your healthcare provider. • Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see What should I do if I miss any Altavera pills? below), you could also feel a little sick to your stomach. • It is not uncommon to miss a period.
However, if you miss a period and have not taken Altavera according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Altavera. • If you have vomiting or diarrhea within 3-4 hours of taking a light-orange pill, take another light-orange pill as soon as possible. Continue taking all your remaining pills in order.
Start the first pill of your next pill pack the day after finishing your current pill pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule. • If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well.
Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider. • Stop taking Altavera at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period. Before you start taking Altavera: • Decide what time of day you want to take your pill.
It is important to take it at the same time every day and in the order as directed on your pill pack. • Look at your pill pack. Your pill pack consists of 1 card that holds 28 individually sealed pills. The 28 pills consist of 21 light-orange pills (3 rows of 7 pills) and 7 pink pills (1 row of 7 pills).
See Figure A . Figure A • Also find: o Where on the card to start taking pills (upper left corner) and o In what order to take the pills (follow the weeks) • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills. When should I start taking Altavera?
If you start taking Altavera and you have not used a hormonal birth control method before: • There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill. • If you use the Sunday Start, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take Altavera.
You do not need back-up contraception if you use the Day 1 Start. If you start taking Altavera and you are switching from another birth control pill: • Start your new Altavera pack on the same day that you would start the next pack of your previous birth control method. • Do not continue taking the pills from your previous birth control pill pack. If you start taking Altavera and previously used a vaginal ring:… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Levonorgestrel/ethinyl estradiol Tab, #28 Label
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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. |