Home NDC 16714-347-02 Philith
Product NDC 16714-347
Requested package NDC 16714-347-02
11-digit product format 167140347
Labeler code 16714
Product ID 16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone and Ethinyl Estradiol Tablets
Dosage form KIT
Route ORAL
Labeler Northstar Rx LLC
Application ANDA090947
Marketing category ANDA
Marketing start 2011-12-22
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 A090947-001 PHILITH ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090947-001 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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090947-001 PHILITH 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-12-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Philith
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 238015 Internal RxNorm lookup 748797 Internal RxNorm lookup 749736 Internal RxNorm lookup 1235874 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 16714-347 PHILITH (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS) KIT [NORTHSTAR RX LLC] 7 Current NDC, Legacy NDC, 8 package rows 20240712_77b8d3ef-f3ac-4148-84f0-f6cb327c9f78.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 · 1 matching rows.
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 16714-347-02 16714034702 1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK 1 blister pack 2011-12-22 0000-00-00 No No Current