Home NDC 68180-873-13 WYMZYA Fe
Product NDC 68180-873
Requested package NDC 68180-873-13
11-digit product format 681800873
Labeler code 68180
Product ID 68180-873_a3be3d49-c5f9-4700-b928-317b0289391f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NORETHINDRONE AND ETHINYL ESTRADIOL
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA091332
Marketing category ANDA
Marketing start 2020-11-30
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091332-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL BX 2016-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET, CHEWABLE / ORAL AB 2016-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091332-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2016-03-23 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base WYMZYA Fe
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 433718 Internal RxNorm lookup 1095223 Internal RxNorm lookup 1095224 Internal RxNorm lookup 1486452 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-832-74 WYMZYA Fe 21 in 1 BLISTER PACK TABLET, CHEWABLE 21 0.4 mg 15 68180-873-73 WYMZYA Fe 1 in 1 POUCH KIT 1 15 68180-873-73 WYMZYA Fe 3 in 1 CARTON KIT 3 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-873 WYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20250515_4f824b11-14f3-4a92-a516-562b3a434df0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WYMZYA Fe NORETHINDRONE AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 4f824b11-14f3-4a92-a516-562b3a434df0 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091332 application number: ANDA091332 ndc (product): 68180-873
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 68180-873-13 68180087313 3 POUCH in 1 CARTON (68180-873-13) > 1 BLISTER PACK in 1 POUCH (68180-873-11) > 1 KIT in 1 BLISTER PACK 3 pouch 2016-12-05 2022-01-31 No No Current