Home DailyMed 9c438e89-98dc-4770-89fe-e4b897d99b75 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:18:50 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091204-001 WERA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091204-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091204-001 WERA 0.035MG;0.5MG TABLET / ORAL-28 AB RS 2012-03-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Wera NORETHINDRONE AND ETHINYL ESTRADIOL Northstar Rx LLC 638e4f36-1a27-4220-8ec9-3fa9d9b36c11 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 16714-370-01 ndc11 (package): 16714037001
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.