Home NDC 70700-164 Levonorgestrel
Product NDC 70700-164
11-digit product format 707000164
Labeler code 70700
Product ID 70700-164_6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c
Type HUMAN OTC DRUG
Nonproprietary name Levonorgestrel
Dosage form TABLET
Route ORAL
Labeler Xiromed LLC
Application ANDA205329
Marketing category ANDA
Marketing start 2020-03-13
Substance LEVONORGESTREL
Active strength 1.5 mg/1
Pharmacologic classes Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [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 A205329-001 LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18
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 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205329-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2018-09-18 f41ea6bd6efb…
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 Levonorgestrel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483325 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 70700-164-06 Levonorgestrel 1 in 1 BLISTER PACK TABLET 1 6 70700-164-06 Levonorgestrel 1 in 1 CARTON TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-164 LEVONORGESTREL TABLET [XIROMED LLC] 6 Current NDC, Legacy NDC, 2 package rows 20230906_626a2333-ff56-ef28-a287-b33bacc0302a.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 · 3 matching rows.
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 70700-164-06 70700016406 1 BLISTER PACK in 1 CARTON (70700-164-06) / 1 TABLET in 1 BLISTER PACK 1 blister pack 2020-03-13 0000-00-00 No No Current