Home NDC 51285-131 Loestrin
Product NDC 51285-131
11-digit product format 512850131
Labeler code 51285
Product ID 51285-131_21f0dbf2-f0a8-447a-a975-482b4194b1eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Teva Women's Health LLC
Application ANDA076380
Marketing category ANDA
Marketing start 2015-02-26
Substance NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active strength 1; 20 mg/1; ug/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 A076380-001 JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076380-001 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 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 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 Loestrin
Brand name suffix 21 Day
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE 1 mg/1 ETHINYL ESTRADIOL 20 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9S44LIC7OJ Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 11 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259176 Internal RxNorm lookup 1358762 Internal RxNorm lookup 1358763 Internal RxNorm lookup 1358770 Internal RxNorm lookup 1358776 Internal RxNorm lookup 1358781 Internal RxNorm lookup 1359022 Internal RxNorm lookup 1359023 Internal RxNorm lookup 1359026 Internal RxNorm lookup 1359028 Internal RxNorm lookup 1359031 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 51285-131-97 Loestrin21 Day 1 in 1 POUCH TABLET 1 12 51285-131-97 Loestrin21 Day 5 in 1 CARTON TABLET 5 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 NORETHINDRONE ACTIVE MOIETY T18F433X4S LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 FERROUS FUMARATE INACTIVE INGREDIENT R5L488RY0Q LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 LOESTRIN 21 1/20 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1/20 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT LOESTRIN 21 1.5/30 21 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET LOESTRIN FE 1.5/30 28 DAY (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51285-131 LOESTRIN 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET LOESTRIN FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH LLC] 12 Current NDC, Legacy NDC, 2 package rows 20250416_f29ebcb5-7e65-4092-bfaa-f5ec026fc255.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Junel FE JUNEL FE Direct_Rx ea62a66e-d45d-11be-e053-2a95a90a7801 2026-03-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 Junel 21 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 8b82ad14-580c-4145-b825-dce849f95363 2025-02-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 Loestrin Fe 28 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Teva Women's Health LLC f29ebcb5-7e65-4092-bfaa-f5ec026fc255 2025-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 ndc (product): 51285-131 Junel 21 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Proficient Rx LP 56e91ad4-f31b-494d-9e75-6dd4f396779c 2024-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380
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 51285-131-97 51285013197 5 POUCH in 1 CARTON (51285-131-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK 5 pouch 2015-02-26 0000-00-00 No No Current