Prescription drug · ANDA
Acetaminophen NDC 68083-648
Acetaminophen 10 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-648-01 | 68083064801 | 24 BAG in 1 CARTON (68083-648-01) / 100 mL in 1 BAGMarketed from Apr 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219215
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-648_04cdb516-3f83-45c4-a608-6a08b1fb6cf0SPL ID 04cdb516-3f83-45c4-a608-6a08b1fb6cf0SPL set ID db5d4cf8-762a-4111-971e-91c704bc3643RxCUI 483017, 2480095UNII 362O9ITL9DUPC 0368083647018, 0368083648015
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J0131 — Injection, acetaminophen, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468083064801followed by a unit qualifier and the quantityPackage 68083-0648-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Acetaminophen Injection is indicated for • the management of mild to moderate pain in adult and pediatric patients 2 years and older • the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older • the reduction of fever in adult and pediatric patients. Acetaminophen Injection is indicated for the • Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) • Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) • Reduction of fever in adult and pediatric patients ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68083-648
- What is NDC 68083-648?
- 68083-648 is the product NDC for Acetaminophen, Acetaminophen 10 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen.
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen?
- 231 other product NDCs are listed under this name. See all Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0131, Injection, acetaminophen, 10 mg. See Billing references above.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-871 | 70069-0871-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 | 00363-9810-1000363-9810-2500363-9810-50+1 more |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Meijer Distribution Inc | 79481-0780 | 79481-0780-0179481-0780-0279481-0780-04 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4132 | 68788-4132-0168788-4132-0268788-4132-03+1 more |
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-008 | 87441-0008-01 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | Acetris Pharma Holdings, LLC | 52343-555 | 52343-0555-12 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-892 | 62207-0892-4962207-0892-51 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Grocery Outlet, Inc. | 85828-102 | 85828-0102-02 |
Other NDCs under ANDA 219215
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-647 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-705 |