TRAMADOL HCL AND ACETAMINOPHEN
- Product NDC
- 69844-049
- 11-digit product format
- 698440049
- Labeler code
- 69844
- Product ID
- 69844-049_15ed3d8f-f49b-4f4c-af73-40ebc96e9040
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HCL AND ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Graviti Pharmaceuticals Private Limited
- Application
- ANDA076914
- Marketing category
- ANDA
- Marketing start
- 2020-04-06
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69844-049-01 | 2025-09-24 | C162847 | 48780-1 | d6a99b39-dfa6-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval - 2001 |
| 69844-049-02 | 2025-09-24 | C162847 | 48780-1 | d6a99b39-dfa6-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval - 2001 |
| 69844-049-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dfa6-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval - 2001 |
| 69844-049-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dfa6-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval - 2001 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69844-049 | TRAMADOL HCL AND ACETAMINOPHEN TABLET, FILM COATED [GRAVITI PHARMACEUTICALS PRIVATE LIMITED] | 1 | Legacy NDC | 20200730_774b7307-147c-43b9-a39a-63059167f295.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69844-049-01 | 69844004901 | 100 TABLET, FILM COATED in 1 BOTTLE (69844-049-01) | 2020-04-06 | 0000-00-00 | No | No | Current |
| 69844-049-02 | 69844004902 | 500 TABLET, FILM COATED in 1 BOTTLE (69844-049-02) | 2020-04-06 | 0000-00-00 | No | No | Current |