Home NDC 16714-365 Elinest
Product NDC 16714-365
11-digit product format 167140365
Labeler code 16714
Product ID 16714-365_cf47f8b4-e64e-4128-a197-54bcce596aa1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Northstar Rx LLC
Application ANDA091105
Marketing category ANDA
Marketing start 2012-01-07
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091105-001 ELINEST ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091105-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091105-001 ELINEST 0.03MG;0.3MG TABLET / ORAL-28 AB 2012-03-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091105-001 AB 1 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Elinest NORGESTREL AND ETHINYL ESTRADIOL Northstar Rx LLC aa7f4a83-71cf-4306-b0a1-01784f67bae2 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091105 application number: ANDA091105 ndc (product): 16714-365
Additional Listing Data#
Finished product Yes
Brand name base Elinest
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311359 Internal RxNorm lookup 748797 Internal RxNorm lookup 749786 Internal RxNorm lookup 1305089 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-365 ELINEST (NORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC] 6 Current NDC, Legacy NDC, 8 package rows 20230626_aa7f4a83-71cf-4306-b0a1-01784f67bae2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-365-01 16714036501 1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACK 1 blister pack 2012-01-07 0000-00-00 No No Current 16714-365-02 16714036502 1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACK 1 blister pack 2012-01-07 0000-00-00 No No Current 16714-365-03 16714036503 3 BLISTER PACK in 1 CARTON (16714-365-03) / 1 KIT in 1 BLISTER PACK 3 blister pack 2012-01-07 0000-00-00 No No Current 16714-365-04 16714036504 6 BLISTER PACK in 1 CARTON (16714-365-04) / 1 KIT in 1 BLISTER PACK 6 blister pack 2012-01-07 0000-00-00 No No Current