ALTAVERA

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: ALTAVERA
Generic name: LEVONORGESTREL AND ETHINYL ESTRADIOL
Manufacturer: Xiromed, LLC.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 4701e72b-6378-a771-fb88-1b703031a8bc
SPL ID: cd0fbf86-78dd-a8f2-7399-112a042ab767
Version: 12
Effective date: 2023-02-10
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:06

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	079102	derived:openfda.application_number
application number		ANDA079102	openfda.application_number
brand name		ALTAVERA	openfda.brand_name
generic name		LEVONORGESTREL AND ETHINYL ESTRADIOL	openfda.generic_name
manufacturer name		Xiromed, LLC.	openfda.manufacturer_name
ndc	package	70700-116-85	openfda.package_ndc
ndc	product	70700-116	openfda.product_ndc
ndc11	package	70700011685	derived:openfda.package_ndc
rxcui		238019	openfda.rxcui
rxcui		748797	openfda.rxcui
rxcui		748878	openfda.rxcui
rxcui		1006065	openfda.rxcui
spl id		cd0fbf86-78dd-a8f2-7399-112a042ab767	id
spl set id		4701e72b-6378-a771-fb88-1b703031a8bc	set_id

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Boxed warning sections page 1 of 1 · 1 matching rows.

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)].

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.