Plan B One-Step
- Product NDC
- 21695-973
- 11-digit product format
- 216950973
- Labeler code
- 21695
- Product ID
- 21695-973_e17b3ec0-7739-4775-b7a2-a262f4f3a836
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021998
- Marketing category
- NDA
- Marketing start
- 2009-07-10
- Marketing end
- 0000-00-00
- Substance
- LEVONORGESTREL
- Active strength
- 2 mg/1
- Pharmacologic classes
- Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-973-01 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a55-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 1982 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-973-01 | Plan B One-Step | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 21695-973-01 | Plan B One-Step | 1 in 1 BLISTER PACK | TABLET | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-973-01 | EA - Each | 21695-973 | c88f08c8-6164-4c43-a384-a62255ed27c4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PLAN B ONE-STEP (LEVONORGESTREL) TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 483325 | levonorgestrel 1.5 MG Oral Tablet | PSN | e17b3ec0-7739-4775-b7a2-a262f4f3a836 | 1 |
| 858079 | Plan B One-Step 1.5 MG Oral Tablet | PSN | e17b3ec0-7739-4775-b7a2-a262f4f3a836 | 1 |
| 858079 | levonorgestrel 1.5 MG Oral Tablet [Plan B One-Step] | SBD | e17b3ec0-7739-4775-b7a2-a262f4f3a836 | 1 |
| 483325 | levonorgestrel 1.5 MG Oral Tablet | SCD | e17b3ec0-7739-4775-b7a2-a262f4f3a836 | 1 |
| 858079 | Plan B One-Step 1.5 MG Oral Tablet | SY | e17b3ec0-7739-4775-b7a2-a262f4f3a836 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-973-01 | 21695097301 | 1 in 1 CARTON | Historical |