FDA.reportPublic FDA data

Balcoltra

Product NDC
75854-602
11-digit product format
758540602
Labeler code
75854
Product ID
75854-602_57bb625e-d567-432d-a6c2-44b329de9b7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levonorgestrel and ethinyl estradiol
Dosage form
KIT
Labeler
Avion Pharmaceuticals
Application
NDA208612
Marketing category
NDA
Marketing start
2018-04-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208612-001BALCOLTRAETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORALAB3RLD, RS2018-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N208612-001AB3

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208612-00178380422027-06-01U-3251Drug substance2021-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208612-001BALCOLTRA0.02MG;0.1MGTABLET / ORALAB3RLD, RS2018-01-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N208612-001AB31a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208612-00178380422027-06-01U-3251Drug substance2021-11-30a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208612
application number: NDA208612
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208612
application number: NDA208612
ndc (product): 75854-602

Additional Listing Data#

Finished product
Yes
Brand name base
Balcoltra
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242297Internal RxNorm lookup
1999026Internal RxNorm lookup
2672922Internal RxNorm lookup
2672923Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
752ab698-4b48-4614-8016-d1d33ee7c007Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75854-602-02Balcoltra1 in 1 BLISTER PACKKIT16
75854-602-02Balcoltra2 in 1 CARTONKIT26
75854-602-03Balcoltra1 in 1 BLISTER PACKKIT16
75854-602-03Balcoltra3 in 1 CARTONKIT36
75854-602-28Balcoltra1 in 1 BLISTER PACKKIT16
75854-602-28Balcoltra1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-602-02EA - Each75854-60218d9116e-db2f-403a-8160-abb897d3f42e12019-01-24
75854-602-03EA - Each75854-6024fe681a6-d009-47a1-8700-565cedea272212018-05-09
75854-602-28EA - Each75854-60238a2e389-f2a2-43e9-8124-9baae43d472712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75854-602BALCOLTRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS]5Current NDC, Legacy NDC, 6 package rows20231123_752ab698-4b48-4614-8016-d1d33ee7c007.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999026{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]BPCK752ab698-4b48-4614-8016-d1d33ee7c0076
2672923{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } PackGPCK752ab698-4b48-4614-8016-d1d33ee7c0076
1999026Balcoltra 28 Day PackPSN752ab698-4b48-4614-8016-d1d33ee7c0076
2672923Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day PackPSN752ab698-4b48-4614-8016-d1d33ee7c0076
2672922ferrous bisglycinate 36.5 MG Oral TabletPSN752ab698-4b48-4614-8016-d1d33ee7c0076
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN752ab698-4b48-4614-8016-d1d33ee7c0076
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD752ab698-4b48-4614-8016-d1d33ee7c0076
2672922ferrous bisglycinate 36.5 MG Oral TabletSCD752ab698-4b48-4614-8016-d1d33ee7c0076
1999026Balcoltra 28 Day PackSY752ab698-4b48-4614-8016-d1d33ee7c0076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75854-602-02758540602022 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK2 blister pack2018-04-100000-00-00NoNoCurrent
75854-602-03758540602033 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK3 blister pack2018-04-100000-00-00NoNoCurrent
75854-602-28758540602281 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK1 blister pack2018-04-100000-00-00NoNoCurrent