Gallifrey
- Product NDC
- 70700-326
- 11-digit product format
- 707000326
- Labeler code
- 70700
- Product ID
- 70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Xiromed LLC
- Application
- ANDA205278
- Marketing category
- ANDA
- Marketing start
- 2024-09-06
- Substance
- NORETHINDRONE ACETATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gallifrey
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE ACETATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9S44LIC7OJ |
| Rxcui | 1000405, 2696255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-326-50 | Gallifrey | 50 in 1 BOTTLE | TABLET | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-326 | GALLIFREY (NORETHINDRONE ACETATE) TABLET [XIROMED LLC] | 1 | Current NDC, 1 package rows | 20241101_26130af6-221b-2349-81b6-0c0132d6e524.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 |
|---|
| 70700-326-50 | 70700032650 | 50 TABLET in 1 BOTTLE (70700-326-50) | 50 tablet | 2024-09-06 | No | No | Historical |