lincomycin hydrochloride
- Product NDC
- 68083-478
- 11-digit product format
- 680830478
- Labeler code
- 68083
- Product ID
- 68083-478_084e1826-51be-4e48-aae4-b6affb80853f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lincomycin hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
- Labeler
- Gland Pharma Limited
- Application
- ANDA215657
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Substance
- LINCOMYCIN HYDROCHLORIDE
- Active strength
- 300 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- lincomycin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LINCOMYCIN HYDROCHLORIDE | 300 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M6T05Z2B68 |
| Rxcui | 239212 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-478-01 | lincomycin hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 68083-478-01 | lincomycin hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-478 | LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220929_c2b5be20-cc6f-4221-9d3e-3f8b5886cd05.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 |
|---|
| 68083-478-01 | 68083047801 | 1 VIAL in 1 CARTON (68083-478-01) / 2 mL in 1 VIAL | 1 vial | 2022-09-26 | 0000-00-00 | No | No | Current |