ALYACEN 1/35
- Product NDC
- 53002-1780
- 11-digit product format
- 530021780
- Labeler code
- 53002
- Product ID
- 53002-1780_543ba0d2-618a-4784-bfa1-0a88cd996b17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091634
- Marketing category
- ANDA
- Marketing start
- 2012-01-19
- 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 table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1780-1 | 2025-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-3 | 2025-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-6 | 2025-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-1 | 2023-06-07 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-3 | 2023-06-07 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-6 | 2023-06-07 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
| 53002-1780-6 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4529-0266-e053-dadaa90a7c1a | ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1780-1 | ALYACEN 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | | 4 |
| 53002-1780-3 | ALYACEN 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | | 4 |
| 53002-1780-3 | ALYACEN 1/35 | 3 in 1 POUCH | KIT | 3 | | 4 |
| 53002-1780-6 | ALYACEN 1/35 | 6 in 1 POUCH | KIT | 6 | | 4 |
| 53002-1780-6 | ALYACEN 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1780 | ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 5 package rows | 20230609_5c4c8517-b81a-4716-be70-1b2b7e7dd146.zip |
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 |
|---|
| 53002-1780-1 | 53002178001 | 1 KIT in 1 BLISTER PACK (53002-1780-1) | 1 kit | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1780-3 | 53002178003 | 3 BLISTER PACK in 1 POUCH (53002-1780-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1780-6 | 53002178006 | 6 BLISTER PACK in 1 POUCH (53002-1780-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |