Acetaminophen
- Product NDC
- 68016-183
- 11-digit product format
- 680160183
- Labeler code
- 68016
- Product ID
- 68016-183_b7b4bf85-8a0e-4b0f-e053-2a95a90abf05
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PHARMACY VALUE ALLIANCE, LLC
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2019-11-15
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68016-183-05 | 2023-01-30 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-10 | 2023-01-30 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-05 | 2020-12-30 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-10 | 2020-12-30 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-05 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-10 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-05 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-10 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-05 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
| 68016-183-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-26fc-f274-e053-dbdaa90a6471 | Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-183-05 | Acetaminophen | 50 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 50 | | 2 |
| 68016-183-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-183 | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [PHARMACY VALUE ALLIANCE, LLC] | 2 | Legacy NDC, 2 package rows | 20201231_8fb0762d-da96-7b54-e053-2995a90a03fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68016-183-05 | 68016018305 | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68016-183-05) | 2019-11-15 | 0000-00-00 | No | No | Current |
| 68016-183-10 | 68016018310 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68016-183-10) | 2019-11-15 | 0000-00-00 | No | No | Current |