Acetaminophen
- Product NDC
- 68083-648
- 11-digit product format
- 680830648
- Labeler code
- 68083
- Product ID
- 68083-648_04cdb516-3f83-45c4-a608-6a08b1fb6cf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA219215
- Marketing category
- ANDA
- Marketing start
- 2025-04-02
- Substance
- ACETAMINOPHEN
- Active strength
- 10 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
- Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 483017, 2480095 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-648-01 | Acetaminophen | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 4 |
| 68083-648-01 | Acetaminophen | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-648 | ACETAMINOPHEN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, 2 package rows | 20250406_db5d4cf8-762a-4111-971e-91c704bc3643.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 |
|---|
| 68083-648-01 | 68083064801 | 24 BAG in 1 CARTON (68083-648-01) / 100 mL in 1 BAG | 24 bag | 2025-04-02 | No | No | Current |