Levonorgestrel
- Product NDC
- 0536-1142
- 11-digit product format
- 005361142
- Labeler code
- 0536
- Product ID
- 0536-1142_bea85d01-936e-46f6-8037-b60d0e39dd05
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA202635
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Marketing end
- 0000-00-00
- Substance
- LEVONORGESTREL
- Active strength
- 2 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0536-1142 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0536-1142 | 0536-1142-63 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202635-001 | OPCICON ONE-STEP | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2014-09-11 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202635-001 | OPCICON ONE-STEP | 1.5MG | TABLET / ORAL | 2014-09-11 | cb3db0bc1861… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1142-63 | EA - Each | 0536-1142 | 1a57364b-a3e1-4094-b7c3-e02fefdbb19e | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LEADER Emergency Contraceptive Levonorgestrel | LEVONORGESTREL | Cardinal Health 110, LLC. DBA Leader | d1e33615-0a98-4223-833d-843c758d9db7 | 2026-05-06 | Warnings | 202635 ANDA202635 |
| Levonorgestrel | LEVONORGESTREL | Ohm Laboratories Inc. | f3f2a41a-a9af-4d63-81d8-33181d12af40 | 2025-07-04 | Warnings | 202635 ANDA202635 |
| Levonorgestrel | LEVONORGESTREL | Thirty Madison Inc. | 6933ae19-4c8f-49a2-96c5-9cdf37ee5824 | 2024-12-30 | Warnings | 202635 ANDA202635 |
| Levonorgestrel | LEVONORGESTREL | Ohm Laboratories Inc. | 5c509934-8c11-4d7f-8506-5971c37cfc22 | 2024-09-06 | Warnings | 202635 ANDA202635 |
| Opcicon One-Step | LEVONORGESTREL | Sun Pharmaceutical Industries, Inc. | b67ca313-561e-471f-baf3-257b7e253c75 | 2023-01-13 | Warnings | 202635 ANDA202635 |
| My Choice TM | LEVONORGESTREL | Proficient Rx LP | 165f7270-d050-4e97-b30f-107b96940d84 | 2022-09-01 | Warnings | 202635 ANDA202635 |
| My Choice TM | LEVONORGESTREL | SUN PHARMACEUTICAL INDUSTRIES, INC. | 66753300-fb61-4f09-af74-ee498b0bd595 | 2022-04-21 | Warnings | 202635 ANDA202635 |
| AfterPlan | LEVONORGESTREL | SUN PHARMACEUTICAL INDUSTRIES, INC. | c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a | 2018-10-26 | Warnings | 202635 ANDA202635 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0536-1142-63 | 00536114263 | 1 BLISTER PACK in 1 CARTON (0536-1142-63) > 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2017-11-01 | 0000-00-00 | No | No | Current |