FDA.reportPublic FDA data

NDC 71671-100-11 - Twirla

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71671-100
Requested NDC
71671-100-11
Package NDCs from labels
71671-100-11, 71671-100-03, 71671-100-01
Manufacturer
Agile Therapeutics, Inc. | Exeltis USA, Inc. | Corium Innovations, Inc.
Effective date
2026-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Twirla - Agile Therapeutics, Inc. | Exeltis USA, Inc. | Corium Innovations, Inc.Agile Therapeutics, Inc. | Exeltis USA, Inc. | Corium Innovations, Inc.2026-06-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71671-100-01Twirla1 in 1 CARTONPATCH17
71671-100-03Twirla3 in 1 CARTONPATCH37
71671-100-11Twirla1 in 1 POUCHPATCH17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71671-100TWIRLA (LEVONORGESTREL/ETHINYL ESTRADIOL) PATCH [AGILE THERAPEUTICS, INC.]6Current NDC, Legacy NDC, 3 package rows20240712_bcaf8db0-1750-425d-b008-255b5e7a9cc6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71671-100-03EA - Each71671-10027eaefda-8d39-4e7e-bfe0-75873545aa8712020-07-13
71671-100-11EA - Each71671-100452e0906-64f9-4ccd-8188-70bbe7a5219812020-07-13

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 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
Dimethyl SulfoxideDIMETHYL SULFOXIDERenova Pharmaceuticals LLC8f699de6-9d09-48da-9d95-4001d70085872026-07-20Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H
NitrogenNITROGENLinde Inc.11f1ea16-93eb-4994-ba96-d0d7519015e22026-07-16Exact identifier
unii: N762921K75
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA204017
ndc (package): 71671-100-03
ndc (package): 71671-100-01
ndc (package): 71671-100-11
ndc (product): 71671-100
ndc11 (package): 71671010011
rxcui: 2396253
rxcui: 2396258
rxcui: 2396259
rxcui: 2396242
spl id: 557e8f45-e388-68b8-e063-6294a90a2586
spl set id: bcaf8db0-1750-425d-b008-255b5e7a9cc6
unii: 423D2T571U
unii: 5W7SIA7YZW
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW
NitrogenNITROGENMaine Oxy-Acetylene Supply Company652ecc66-c6bb-40a3-a12f-64c7a4cdaca82026-06-18Exact identifier
unii: N762921K75
NitrogenNITROGENArcet Equipment Company dba Arc3 Gases Northff2ba9fb-e58a-4e57-8e96-b7e90cc6e2a82026-06-18Exact identifier
unii: N762921K75
NITROGEN Compressed, NFNITROGENAIRGAS USA, LLC6638a09f-7d87-48ce-934b-5edb3891ad612026-06-15Exact identifier
unii: N762921K75
Nitrogen, RefrigeratedNITROGEN, REFRIGERATEDAirgas Usa, LLC9c536407-8936-4a32-91c2-22712ae2c1f22026-06-15Exact identifier
unii: N762921K75
NitrogenNITROGENTerry Supply Company Inc52e5a40a-e974-929e-e063-6294a90aa5772026-05-28Exact identifier
unii: N762921K75
NitrogenNITROGENAmerican Welding & Gasda044445-31cc-477e-92f8-88d6e3ec5eff2026-05-21Exact identifier
unii: N762921K75
NitrogenNITROGENNexAir, LLC4da119c6-59e9-4f95-9c0c-483b5e2162fb2026-05-21Exact identifier
unii: N762921K75
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
unii: 5W7SIA7YZW
NitrogenNITROGENUCG Georgia, LLC7b077025-c8f6-2790-e053-2991aa0aa9c22026-05-11Exact identifier
unii: N762921K75
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
NitrogenNITROGENWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.1017e562-498d-9554-e063-6394a90ab5662026-04-28Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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