Cryselle
- Product NDC
- 53002-1188
- 11-digit product format
- 530021188
- Labeler code
- 53002
- Product ID
- 53002-1188_06b31305-faf3-41bd-b589-02485c928bad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075840
- Marketing category
- ANDA
- Marketing start
- 2002-07-24
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-1188-1 | 2025-01-30 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 53002-1188-3 | 2025-01-30 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 53002-1188-1 | 2023-06-07 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 53002-1188-3 | 2023-06-07 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 53002-1188-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
| 53002-1188-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-162d-0266-e053-dadaa90a7c1a | Cryselle ® (norgestrel and ethinyl estradiol tablets USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1188-1 | Cryselle | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 53002-1188-3 | Cryselle | 3 in 1 POUCH | KIT | 3 | 3 | |
| 53002-1188-3 | Cryselle | 1 in 1 BLISTER PACK | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1188 | CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20230609_9ef8ffe1-5cba-47dc-a405-dd523d76abb5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 750265 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28] | BPCK | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 750265 | Cryselle 28 Day Pack | PSN | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 748797 | inert 1 MG Oral Tablet | PSN | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 750265 | Cryselle 28 Day Pack | SY | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | 9ef8ffe1-5cba-47dc-a405-dd523d76abb5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1188-1 | 53002118801 | 1 KIT in 1 BLISTER PACK (53002-1188-1) | 1 kit | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1188-3 | 53002118803 | 3 BLISTER PACK in 1 POUCH (53002-1188-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |