Home NDC 70700-152 Gemmily
Product NDC 70700-152
11-digit product format 707000152
Labeler code 70700
Product ID 70700-152_da57e58b-738f-0ef3-d2a5-427bc267ed19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Dosage form KIT
Labeler Xiromed, LLC
Application ANDA213317
Marketing category ANDA
Marketing start 2020-11-09
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 42 .
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 A213317-001 GEMMILY ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213317-001 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 2026-08-18 06:07:40 2026-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213317-001 GEMMILY 0.02MG;1MG CAPSULE / ORAL AB 2020-11-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gemmily
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 1421459 Internal RxNorm lookup 1421460 Internal RxNorm lookup 1421461 Internal RxNorm lookup 2463741 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 70700-152-84 Gemmily 1 in 1 BLISTER PACK KIT 1 5 70700-152-84 Gemmily 1 in 1 CARTON KIT 1 5 70700-152-85 Gemmily 3 in 1 CARTON KIT 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-152 GEMMILY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [XIROMED, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20230809_6ca786fb-8f28-d2ac-5d8d-a14c3af6d7a7.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 Gemmily NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE Xiromed, LLC 6ca786fb-8f28-d2ac-5d8d-a14c3af6d7a7 2023-07-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213317 application number: ANDA213317 ndc (product): 70700-152
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 70700-152-84 70700015284 1 in 1 BLISTER PACK Historical 70700-152-85 70700015285 3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK 3 carton 2020-11-09 0000-00-00 No No Current