IBANDRONATE SODIUM
- Product NDC
- 69452-378
- 11-digit product format
- 694520378
- Labeler code
- 69452
- Product ID
- 69452-378_7c860070-7f7a-4217-9cfb-f5536fd736b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBANDRONATE SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA078998
- Marketing category
- ANDA
- Marketing start
- 2023-05-26
- Substance
- IBANDRONATE SODIUM
- Active strength
- 150 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IBANDRONATE SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBANDRONATE SODIUM | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J12U072QL0 |
| Rxcui | 904932 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-378-74 | IBANDRONATE SODIUM | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 69452-378-74 | IBANDRONATE SODIUM | 3 in 1 BLISTER PACK | TABLET | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-378 | IBANDRONATE SODIUM TABLET [BIONPHARMA INC.] | 2 | Current NDC, 2 package rows | 20230526_6ca94cce-a2bb-421f-bd8f-6b14bc2bd985.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 |
|---|
| 69452-378-74 | 69452037874 | 1 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-05-26 | No | No | Current |