POLYMYXIN B
- Product NDC
- 68083-174
- 11-digit product format
- 680830174
- Labeler code
- 68083
- Product ID
- 68083-174_0f89d7be-ad20-46d1-8cce-0cee8ee572cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POLYMYXIN B SULFATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA207322
- Marketing category
- ANDA
- Marketing start
- 2016-06-01
- Substance
- POLYMYXIN B SULFATE
- Active strength
- 500000 [USP'U]/1
- Pharmacologic classes
- Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- POLYMYXIN B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYMYXIN B SULFATE | 500000 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19371312D4 |
| Rxcui | 204509 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-174-01 | POLYMYXIN B | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 68083-174-10 | POLYMYXIN B | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-174 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250514_dc74dee2-1d0b-4fab-a29b-1755fdb5da75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-174-01 | 68083017401 | 1 in 1 VIAL | | | | | | Historical |
| 68083-174-10 | 68083017410 | 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01) | 10 vial | 2016-06-01 | 0000-00-00 | No | No | Current |