Over-the-counter drug · ANDA
Muscle Aches and Pains Acetaminophen extended release (Acetaminophen) NDC 49483-704
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-704-05 | 4948307040549483070405 | 1 BOTTLE in 1 CARTON (49483-704-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 7, 2022 |
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)
- Muscle Aches and Pains Acetaminophen extended release
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
- Marketing start
- Listing expires
- Identifiers
- Product ID 49483-704_02a5f067-4b67-ecc7-e063-6294a90a92c3SPL ID 02a5f067-4b67-ecc7-e063-6294a90a92c3SPL set ID cd4d0ad4-7206-94c8-e053-2a95a90aaa14RxCUI 1148399UNII 362O9ITL9DUPC 0349483699401, 0349483699265, 0349483704051, 0349483699425, 0349483699012
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 codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449483070405followed by a unit qualifier and the quantityPackage 49483-0704-05. 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 .
Indications (excerpt from the label)
Uses For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 49483-704
- What is NDC 49483-704?
- 49483-704 is the product NDC for Muscle Aches and Pains Acetaminophen extended release, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Muscle Aches and Pains Acetaminophen extended release (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Muscle Aches and Pains Acetaminophen extended release?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 215486
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 |
|---|---|---|---|---|
| 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-704 |
| Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-699 |
| 8HR Arthritis Pain Reliefacetaminophen 650mg | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-969 |
| 8HR Muscle Aches and Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0734 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TIME CAP LABORATORIES, INC. | 49483-699 |
| Arthritis Pain Relieveracetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALGREENS | 0363-9781 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-034 |
| Acetaminophen Extended-Release Tablets, 650 mgacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-071 |
| 8 hr Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DOLGENCORP, INC. | 55910-892 |
| Acetaminophen Extended-Release Tablets, 650 mgacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-108 |
| 8 hr Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DOLGENCORP, INC. | 55910-895 |
| 8HR Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0733 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | BETTER LIVING BRANDS, LLC | 21130-097 |
| 8HR Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TARGET CORPORATION | 11673-928 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9746 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-914 |
| 8hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7561 |
| 8 Hr Muscle Aches And Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-354 |
| Arthritis Pain Acetaminophenacetaminophen | Acetaminophen 650 mg/1 | TabletOral | TARGET CORPORATION | 11673-673 |