Ibandronate Sodium
- Product NDC
- 55150-191
- 11-digit product format
- 551500191
- Labeler code
- 55150
- Product ID
- 55150-191_9e93dc68-5558-4271-9f1f-44f4313babae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibandronate Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205332
- Marketing category
- ANDA
- Marketing start
- 2015-08-19
- Substance
- IBANDRONATE SODIUM
- Active strength
- 3 mg/3mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| fca0fe5b-9e2b-f6fc-e68d-b5f751d08578 | Product name | 3 | 20180103 |
| a7e2afc7-9184-42ab-b6c6-6edca00dd2d2 | Product name | 4 | 20160310 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55150-191-83 | Ibandronate Sodium | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | 11 | |
| 55150-191-83 | Ibandronate Sodium | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55150-191-83 | ML - Milliliter | 55150-191 | ac8edd54-29e0-41d7-b02a-76def1e40357 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IBANDRONATE SODIUM | ACTIVE INGREDIENT | J12U072QL0 | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 | |
| IBANDRONIC ACID | ACTIVE MOIETY | UMD7G2653W | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IBANDRONATE SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904952 | ibandronate sodium 3 MG in 3 ML Prefilled Syringe | PSN | e81f2c5b-bead-48ac-be3e-016cf963d7ed | 11 |
| 904952 | 3 ML ibandronic acid 1 MG/ML Prefilled Syringe | SCD | e81f2c5b-bead-48ac-be3e-016cf963d7ed | 11 |
| 904952 | ibandronic acid 3 MG (as ibandronate sodium 3.39 MG) per 3 ML Prefilled Syringe | SY | e81f2c5b-bead-48ac-be3e-016cf963d7ed | 11 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55150-191-83 | 55150019183 | 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) / 3 mL in 1 SYRINGE, GLASS | 2015-08-19 | 0000-00-00 | No | No | Current |