LEVONORGESTREL
- Product NDC
- 73581-017
- 11-digit product format
- 735810017
- Labeler code
- 73581
- Product ID
- 73581-017_5a71b889-7472-8e4f-e063-6394a90ac4c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LEVONORGESTREL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- YYBA CORP
- Application
- ANDA219102
- Marketing category
- ANDA
- Marketing start
- 2026-09-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219102-001 | LEVONORGESTREL | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A219102-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A219102-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A219102-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219102-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219102-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2025-09-30 | a50c72e98297… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVONORGESTREL | 1.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5W7SIA7YZW | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 483325 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a71b870-9a0a-7997-e063-6294a90a882c | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| LEVONORGESTREL | LEVONORGESTREL | YYBA CORP | 5a71b870-9a0a-7997-e063-6294a90a882c | 2026-09-01 | Warnings | 219102 ANDA219102 73581-017 |
| LEVONORGESTREL | LEVONORGESTREL | Camber Consumer Care Inc | 2e22d0c4-b308-4a02-b2b0-2c06fb91d1e5 | 2026-03-23 | Warnings | 219102 ANDA219102 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 73581-017-01 | 73581001701 | 1 BLISTER PACK in 1 CARTON (73581-017-01) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2026-09-01 | No | No | Current |