FDA.reportPublic FDA data

{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]

RxCUI
1999026
RxNorm name
{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]
Display name
BALCOLTRA 28 DAY (Pack)
Full name
{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]
Term type
BPCK
Status
Active
Strength
mixed
Dose form
Pack
Route
Pack
Updated
2026-11-04 11:33:25

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032018
Active start
032018
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
ferrous bisglycinate36.5 MG / 1 EACHferrous bisglycinateferrous bisglycinate
ethinyl estradiol0.02 MG / 1 EACHethinyl estradiolethinyl estradiol
levonorgestrel0.1 MG / 1 EACHlevonorgestrellevonorgestrel

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Pack746839

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
ferrous bisglycinate1102188
ethinyl estradiol4124
levonorgestrel6373

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRBalcoltra 28 Day Pack1NAMES
RxNorm Name{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]1NAMES
RxNorm SynonymBalcoltra 28 Day Pack1NAMES
TTYBPCK1ATTRIBUTES
SPL_SET_ID752ab698-4b48-4614-8016-d1d33ee7c0071CODES
RxCUI19990261CODES
MMSL_CODEBD334631CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
75854-602-0275854-602Balcoltra levonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDA208612
75854-602-0375854-602Balcoltra levonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDA208612
75854-602-2875854-602Balcoltra levonorgestrel and ethinyl estradiolAvion PharmaceuticalsNDA208612

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20861275854-602Balcoltra levonorgestrel and ethinyl estradiolNDAAvion Pharmaceuticals

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
75854060202rxnav_ndcsyes
75854060203rxnav_ndcsyes
75854060228rxnav_ndcsyes
75854000028rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 75854-602-28
ndc (package): 75854-602-03
ndc (package): 75854-602-02
ndc (product): 75854-602
ndc11 (package): 75854060202
ndc11 (package): 75854060203
ndc11 (package): 75854060228
rxcui: 1999026

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
752ab698-4b48-4614-8016-d1d33ee7c007{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day] [BPCK] · Balcoltra 28 Day Pack [PSN] · Balcoltra 28 Day Pack [SY]36These highlights do not include all the information needed to use BALCOLTRA ® safely and effectively. See Full Prescribing Information for BALCOLTRA ® . BALCOLTRA ® (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for oral administration Initial U.S. Approval: 199720251205

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
752ab698-4b48-4614-8016-d1d33ee7c007These highlights do not include all the information needed to use BALCOLTRA ® safely and effectively. See Full Prescribing Information for BALCOLTRA ® . BALCOLTRA ® (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for oral administration Initial U.S. Approval: 1997Avion Pharmaceuticals | Novast Laboratories, Ltd.20251205

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG03ADEmergency contraceptivesATC1-4levonorgestrel
ATCL02AAEstrogensATC1-4ethinyl estradiol
ATCG03CANatural and semisynthetic estrogens, plainATC1-4ethinyl estradiol
ATCG03ACProgestogensATC1-4levonorgestrel
ATCG03AAProgestogens and estrogens, fixed combinationsATC1-4ethinyl estradiol / levonorgestrel
ATCG03ABProgestogens and estrogens, sequential preparationsATC1-4ethinyl estradiol / levonorgestrel
FDASPLD045167Progesterone CongenersCHEMhas_chemical_structurelevonorgestrel
FDASPLN0000175825EstrogenEPChas_epcethinyl estradiol
FDASPLN0000175602ProgestinEPChas_epclevonorgestrel
FDASPLN0000175832Progestin-containing Intrauterine SystemEPChas_epclevonorgestrel
FDASPLN0000000100Estrogen Receptor AgonistsMOAhas_moaethinyl estradiol
FDASPLN0000175830Inhibit Ovum FertilizationPEhas_pelevonorgestrel
MEDRTD004997Ethinyl EstradiolCHEMhas_ingredientethinyl estradiol
MEDRTD005296Ferrous CompoundsCHEMhas_ingredientferrous bisglycinate
MEDRTD005998GlycineCHEMhas_ingredientferrous bisglycinate
MEDRTD016912LevonorgestrelCHEMhas_ingredientlevonorgestrel
MEDRTD000022Abortion, SpontaneousDISEASEinduceslevonorgestrel
MEDRTD018248Adenoma, Liver CellDISEASEci_withlevonorgestrel
MEDRTD001943Breast NeoplasmsDISEASEci_withlevonorgestrel
MEDRTD001943Breast NeoplasmsDISEASEci_withethinyl estradiol
MEDRTD001943Breast NeoplasmsDISEASEmay_treatethinyl estradiol
MEDRTD002539Cerebral Arterial DiseasesDISEASEci_withethinyl estradiol
MEDRTD002561Cerebrovascular DisordersDISEASEci_withlevonorgestrel
MEDRTD003324Coronary Artery DiseaseDISEASEci_withethinyl estradiol
MEDRTD003327Coronary DiseaseDISEASEci_withlevonorgestrel
MEDRTD003920Diabetes MellitusDISEASEci_withlevonorgestrel
MEDRTD004342Drug HypersensitivityDISEASEci_withlevonorgestrel
MEDRTD004342Drug HypersensitivityDISEASEci_withethinyl estradiol
MEDRTD016889Endometrial NeoplasmsDISEASEci_withethinyl estradiol
MEDRTD016889Endometrial NeoplasmsDISEASEci_withlevonorgestrel
MEDRTD020773Headache DisordersDISEASEci_withlevonorgestrel
MEDRTD006349Heart Valve DiseasesDISEASEci_withlevonorgestrel
MEDRTD019584Hot FlashesDISEASEmay_treatethinyl estradiol
MEDRTD006973HypertensionDISEASEci_withlevonorgestrel
MEDRTD006973HypertensionDISEASEci_withethinyl estradiol
MEDRTD007006HypogonadismDISEASEmay_treatethinyl estradiol
MEDRTD007565JaundiceDISEASEci_withlevonorgestrel
MEDRTD007674Kidney DiseasesDISEASEci_withlevonorgestrel
MEDRTD008107Liver DiseasesDISEASEci_withethinyl estradiol
MEDRTD008107Liver DiseasesDISEASEci_withlevonorgestrel
MEDRTD008113Liver NeoplasmsDISEASEci_withlevonorgestrel
MEDRTD008594Menopause, PrematureDISEASEmay_treatethinyl estradiol
MEDRTD008595MenorrhagiaDISEASEmay_treatethinyl estradiol
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withethinyl estradiol
MEDRTD015663Osteoporosis, PostmenopausalDISEASEmay_preventethinyl estradiol
MEDRTD011247PregnancyDISEASEci_withlevonorgestrel
MEDRTD011247PregnancyDISEASEmay_preventlevonorgestrel
MEDRTD011247PregnancyDISEASEmay_preventethinyl estradiol
MEDRTD011247PregnancyDISEASEci_withethinyl estradiol
MEDRTD016649Primary Ovarian InsufficiencyDISEASEmay_treatethinyl estradiol
MEDRTD011471Prostatic NeoplasmsDISEASEmay_treatethinyl estradiol
MEDRTD013923ThromboembolismDISEASEci_withlevonorgestrel
MEDRTD013923ThromboembolismDISEASEci_withethinyl estradiol
MEDRTD013924ThrombophlebitisDISEASEci_withlevonorgestrel
MEDRTD013924ThrombophlebitisDISEASEci_withethinyl estradiol
MEDRTD064424Tobacco UseDISEASEci_withethinyl estradiol
MEDRTD014029Tobacco Use DisorderDISEASEci_withlevonorgestrel
MEDRTD014592Uterine HemorrhageDISEASEci_withlevonorgestrel
MEDRTN0000000100Estrogen Receptor AgonistsMOAhas_moaethinyl estradiol
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moalevonorgestrel
MEDRTN0000008311Bone Formation StimulationPEhas_peethinyl estradiol
MEDRTN0000008595Decreased Embryonic ImplantationPEhas_pelevonorgestrel
MEDRTN0000008595Decreased Embryonic ImplantationPEhas_peethinyl estradiol
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_pelevonorgestrel
MEDRTN0000178478Increased Blood PressurePEci_pelevonorgestrel
MEDRTN0000009717Inhibit OvulationPEhas_peethinyl estradiol
MEDRTN0000009717Inhibit OvulationPEhas_pelevonorgestrel
MEDRTN0000009902Vaginal Function AlterationPEhas_peethinyl estradiol
MEDRTN0000008289Aromatic hydroxylationPKhas_pkethinyl estradiol
MEDRTN0000000045Fecal ExcretionPKhas_pkethinyl estradiol
MEDRTN0000000026Hepatic MetabolismPKhas_pkethinyl estradiol
MEDRTN0000000042Renal ExcretionPKhas_pkethinyl estradiol

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA208612
CODESVUID4037489
NAMESPrescribable SynonymBalcoltra 28 Day Pack
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceVeterans Health Administration National Drug File