Nora BE
- Product NDC
- 0480-3475
- 11-digit product format
- 004803475
- Labeler code
- 0480
- Product ID
- 0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- NDA017060
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-12-01
- Substance
- NORETHINDRONE
- Active strength
- .35 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
- Nora BE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE | .35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T18F433X4S |
| Rxcui | 198042, 748961, 748977 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-3475-16 | Nora BE | 6 in 1 CARTON | TABLET | 6 | | 3 |
| 0480-3475-16 | Nora BE | 28 in 1 PACKAGE | TABLET | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3475 | NORA BE (NORETHINDRONE) TABLET [TEVA PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20241102_426ac898-7745-4645-bf9b-bae319e260e8.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 |
|---|
| 0480-3475-16 | 00480347516 | 6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE | 6 package | 2023-12-01 | No | No | Current |