FDA.reportPublic FDA data

VyLibra

Product NDC
50102-235
11-digit product format
501020235
Labeler code
50102
Product ID
50102-235_3fdecb52-8f86-4699-b7e9-6fff08a4267e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Afaxys Pharma, LLC
Application
ANDA205449
Marketing category
ANDA
Marketing start
2016-07-07
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
A205449-001MILIETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205449-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-073f01610625f2…
2019-09-15 20:21 UTC2019-09A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205449-001MILI0.035MG;0.25MGTABLET / ORAL-28AB2016-07-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205449-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205449-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205449-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205449-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205449-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205449-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205449-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205449-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205449-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205449-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205449-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205449-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205449-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205449-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205449-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205449-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205449-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205449-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205449-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205449-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205449-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205449-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205449-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205449-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205449-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205449-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205449-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205449-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205449-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205449-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205449-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205449-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205449-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205449-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205449-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205449-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205449-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205449-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205449-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205449-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
VyLibra
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
240128Internal RxNorm lookup
748797Internal RxNorm lookup
749860Internal RxNorm lookup
1994758Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3Available 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
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
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
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50102-235-11VyLibra1 in 1 BLISTER PACKKIT18
50102-235-11VyLibra1 in 1 CARTONKIT18
50102-235-13VyLibra3 in 1 CARTONKIT38
50102-235-13VyLibra1 in 1 BLISTER PACKKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-235-11EA - Each50102-23514e8d6f1-7987-4c45-ab03-15a3e9350e0712018-03-08
50102-235-13EA - Each50102-235fe851c19-85f4-4860-adf9-5a2aff6b19b112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50102-235VYLIBRA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AFAXYS PHARMA, LLC]8Current NDC, Legacy NDC, 4 package rows20250117_13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205449
application number: ANDA205449
ndc (product): 50102-235
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205449
application number: ANDA205449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1994758{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [VyLibra 28 Day]BPCK13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
748797inert 1 MG Oral TabletPSN13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
1994758VyLibra 28 Day PackPSN13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
748797inert ingredients 1 MG Oral TabletSCD13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
1994758VyLibra 28 Day PackSY13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc38
1994758{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [VyLibra 28 Day]BPCKe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
748797inert 1 MG Oral TabletPSNe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSNe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
1994758VyLibra 28 Day PackPSNe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCDe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
748797inert ingredients 1 MG Oral TabletSCDe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSYe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3
1994758VyLibra 28 Day PackSYe5b71df3-d99e-4e2d-a0cf-4c2790a6907d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50102-235-11501020235111 BLISTER PACK in 1 CARTON (50102-235-11) / 1 KIT in 1 BLISTER PACK1 blister pack2016-07-070000-00-00NoNoCurrent
50102-235-13501020235133 BLISTER PACK in 1 CARTON (50102-235-13) / 1 KIT in 1 BLISTER PACK3 blister pack2016-07-070000-00-00NoNoCurrent