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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui240128, 748797, 749860, 1994758

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

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