Home NDC 75907-087 Zovia 1/35
Product NDC 75907-087
11-digit product format 759070087
Labeler code 75907
Product ID 75907-087_02181767-b236-4c8f-95b8-00d5e3ef5455
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethynodiol Diacetate and Ethinyl Estradiol Tablets
Dosage form KIT
Labeler Dr. Reddy�s Laboratories Inc.
Application ANDA209548
Marketing category ANDA
Marketing start 2024-06-01
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 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 A209548-001 LO-MALMOREDE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209548-001 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 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209548-001 LO-MALMOREDE 0.035MG;1MG TABLET / ORAL-28 AB 2019-02-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Zovia 1/35
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 310228 Internal RxNorm lookup 748797 Internal RxNorm lookup 748804 Internal RxNorm lookup 748859 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 75907-087-28 Zovia 1/35 1 in 1 BLISTER PACK KIT 1 2 75907-087-28 Zovia 1/35 1 in 1 PACKET KIT 1 2 75907-087-62 Zovia 1/35 6 in 1 CARTON KIT 6 2 75907-087-62 Zovia 1/35 1 in 1 BLISTER PACK KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-087 ZOVIA 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS) KIT [DR. REDDY’S LABORATORIES INC.] 2 Current NDC, 4 package rows 20240601_fb636d42-cc1d-47f7-974d-c97c79207f3e.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75907-087-28 75907008728 1 BLISTER PACK in 1 PACKET (75907-087-28) / 1 KIT in 1 BLISTER PACK 1 blister pack 2024-06-01 No No Current 75907-087-62 75907008762 6 BLISTER PACK in 1 CARTON (75907-087-62) / 1 KIT in 1 BLISTER PACK 6 blister pack 2024-06-01 No No Current