FDA.reportPublic FDA data

Opill

Product NDC
0113-8101
11-digit product format
001138101
Labeler code
0113
Product ID
0113-8101_fb2ad1e4-4e8a-4cee-a6e8-a823401dd8fe
Type
HUMAN OTC DRUG
Nonproprietary name
norgestrel
Dosage form
TABLET
Route
ORAL
Labeler
L. Perrigo Company
Application
NDA017031
Marketing category
NDA
Marketing start
2024-03-04
Substance
NORGESTREL
Active strength
.075 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORGESTREL.075 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3J8Q1747Z2
Rxcui203717, 762335, 2676107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-8101-01Opill28 in 1 BLISTER PACKTABLET284
0113-8101-01Opill1 in 1 CARTONTABLET14
0113-8101-03Opill3 in 1 CARTONTABLET34
0113-8101-03Opill28 in 1 BLISTER PACKTABLET284
0113-8101-04Opill4 in 1 PACKAGETABLET44
0113-8101-04Opill28 in 1 BLISTER PACKTABLET284
0113-8101-06Opill28 in 1 BLISTER PACKTABLET284
0113-8101-06Opill6 in 1 CARTONTABLET64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-8101-01EA - Each0113-810194ea3eea-61bf-4b8c-84d6-66a71c96b48612024-04-05
0113-8101-03EA - Each0113-81013d1324b8-998a-49a1-9672-5c67787fce4e12024-04-05
0113-8101-04EA - Each0113-8101657db9a4-6048-4c63-b75d-b8edec0833be12024-06-10
0113-8101-06EA - Each0113-81015eb27d4e-548d-4bfd-8acd-10d24acc235a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-8101OPILL (NORGESTREL) TABLET [L. PERRIGO COMPANY]4Current NDC, 8 package rows20250129_69dfa2ac-6a7e-4587-929c-9acabd97973b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2676107{28 (norgestrel 0.075 MG Oral Tablet) } Pack [Opill 28 Day]BPCK69dfa2ac-6a7e-4587-929c-9acabd97973b4
762335{28 (norgestrel 0.075 MG Oral Tablet) } PackGPCK69dfa2ac-6a7e-4587-929c-9acabd97973b4
203717norgestrel 75 MCG Oral TabletPSN69dfa2ac-6a7e-4587-929c-9acabd97973b4
2676107Opill 28 Day PackPSN69dfa2ac-6a7e-4587-929c-9acabd97973b4
203717norgestrel 0.075 MG Oral TabletSCD69dfa2ac-6a7e-4587-929c-9acabd97973b4
762335Norgestrel 0.075 MG Oral Tablet 28 Count PackSY69dfa2ac-6a7e-4587-929c-9acabd97973b4
2676107Opill 28 Day PackSY69dfa2ac-6a7e-4587-929c-9acabd97973b4
2676107{28 (norgestrel 0.075 MG Oral Tablet) } Pack [Opill 28 Day]BPCK303264da-c919-e0ce-e063-6394a90a4cc73
762335{28 (norgestrel 0.075 MG Oral Tablet) } PackGPCK303264da-c919-e0ce-e063-6394a90a4cc73
203717norgestrel 75 MCG Oral TabletPSN303264da-c919-e0ce-e063-6394a90a4cc73
2676107Opill 28 Day PackPSN303264da-c919-e0ce-e063-6394a90a4cc73
203717norgestrel 0.075 MG Oral TabletSCD303264da-c919-e0ce-e063-6394a90a4cc73
762335Norgestrel 0.075 MG Oral Tablet 28 Count PackSY303264da-c919-e0ce-e063-6394a90a4cc73
2676107Opill 28 Day PackSY303264da-c919-e0ce-e063-6394a90a4cc73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-8101-01001138101011 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK1 blister pack2024-03-04NoNoHistorical
0113-8101-03001138101033 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK3 blister pack2024-03-04NoNoHistorical
0113-8101-04001138101044 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK4 blister pack2024-03-22NoNoHistorical
0113-8101-06001138101066 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK6 blister pack2024-03-04NoNoHistorical