Oxytocin
- Product NDC
- 65219-021
- 11-digit product format
- 652190021
- Labeler code
- 65219
- Product ID
- 65219-021_9ac3d1b0-5944-4a20-87b1-423a712f429a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYTOCIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA018248
- Marketing category
- NDA
- Marketing start
- 2024-05-06
- Substance
- OXYTOCIN
- Active strength
- 10 [USP'U]/mL
- Pharmacologic classes
- Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxytocin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYTOCIN | 10 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1JQS135EYN |
| Rxcui | 1791721 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-021-00 | Oxytocin | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
| 65219-021-01 | Oxytocin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-021 | OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 2 package rows | 20250409_4c4c4b69-8bf7-472c-aafe-29805ba5c965.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 |
|---|
| 65219-021-00 | 65219002100 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 65219-021-01 | 65219002101 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00) | | 2024-05-06 | No | No | Current |