GALBRIELA
- Product NDC
- 70700-306
- 11-digit product format
- 707000306
- Labeler code
- 70700
- Product ID
- 70700-306_8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone and ethinyl estradiol and ferrous fumarate
- Dosage form
- KIT
- Labeler
- Xiromed, LLC
- Application
- ANDA203371
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GALBRIELA
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1095223, 1099638, 1607990, 2704559 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-306-84 | GALBRIELA | 1 in 1 BLISTER PACK | KIT | 1 | | 4 |
| 70700-306-84 | GALBRIELA | 1 in 1 POUCH | KIT | 1 | | 4 |
| 70700-306-85 | GALBRIELA | 3 in 1 CARTON | KIT | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-306 | GALBRIELA (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [XIROMED, LLC] | 4 | Current NDC, 3 package rows | 20250207_47465e7e-64f2-690b-166e-0e1c3e5bec7a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70700-306-84 | 70700030684 | 1 in 1 BLISTER PACK | | | | | Historical |
| 70700-306-85 | 70700030685 | 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2025-01-29 | No | No | Current |