ALTAVERA — Kit

Overview

Brand name

ALTAVERA

Generic name

Levonorgestrel and Ethinyl Estradiol

Dosage form

Kit

Route

—

Marketing category

ANDA · ANDA

Labeler

Bryant Ranch Prepack

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

0

NDC product codes

2

Packages

2

Data completeness

77% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory

Dosage form

Kit

Route of administration

—

Presentations

4

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

079102

Application type

ANDA · Abbreviated New Drug Application

Approval date

August 3, 2010

Sponsor

XIROMED

Products on application

1

Submissions recorded

7

Products approved under application 079102.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
079102-001	ALTAVERA	TABLET		ETHINYL ESTRADIOL; LEVONORGESTREL	Prescription	AB

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

No

Reference Standard

No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 079102.
Type	No.	Action	Status	Date	Review
Supplement	12	Labeling	Approved	April 29, 2022	Standard
Supplement	10	Labeling	Approved	March 4, 2022	Standard
Supplement	9	Labeling	Approved	March 3, 2020	Standard
Supplement	8	Labeling	Approved	August 9, 2017	Standard
Supplement	6	Labeling	Approved	February 25, 2014	Standard
Supplement	2	Labeling	Approved	May 24, 2011	—
Original application	1		Approved	August 3, 2010	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230210). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20230210

Boxed Warning

openFDA Drug Labeling

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

openFDA Drug Labeling

INDICATIONS AND USAGE Altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Description

openFDA Drug Labeling

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.

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED/STORAGE AND HANDLING Altavera tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/30 mcg) are available in a carton containing three blister cards, each containing 28 tablets: 21 Active Tablets: Peach, round, unscored, debossed with SZ on one side and J4 on the other side. 7 Inert Tablets: White, round, unscored, debossed with SZ on one side and J1 on the other side. 1 individual blister NDC 70700-116-84 Carton with 3 blisters NDC 70700-116-85 Store at 20o to 25°C (68° to 77o F) [See USP Controlled Room Temperature]. ALTAVERA is a registered trademark of Xiromed Pharma España, S.L. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain PI-116-06 Rev. 02/2023

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class III	October 17, 2018	Xiromed LLC	Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
63629-2343-1	63629-2343	Bryant Ranch Prepack	3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	January 1, 2018
70700-116-85	70700-116	Xiromed, LLC.	3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK	March 2, 2023
63629-2343	63629-2343	Bryant Ranch Prepack	—	January 1, 2018
70700-116	70700-116	Xiromed, LLC.	—	September 1, 2022

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
Enforcement	FDA	Recall records

Generated September 25, 2026 · 9 sections on this page.