NAPROXEN
- Product NDC
- 66336-815
- 11-digit product format
- 663360815
- Labeler code
- 66336
- Product ID
- 66336-815_f9f24b7c-2184-463c-bd18-70edd0b271db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NAPROXEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA091416
- Marketing category
- ANDA
- Marketing start
- 2012-02-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66336-815-30 | 2019-11-27 | C162847 | 48780-1 | 9855d018-dd4e-cd31-e053-dbdaa90ab51a | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
| 66336-815-60 | 2019-11-27 | C162847 | 48780-1 | 9855d018-dd4e-cd31-e053-dbdaa90ab51a | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66336-815-30 | NAPROXEN | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 66336-815-60 | NAPROXEN | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66336-815-30 | EA - Each | 66336-815 | f3986c7f-be4d-47e2-8ba6-cbf4406bd894 | 1 | 2013-08-02 |
| 66336-815-60 | EA - Each | 66336-815 | 15e82bac-c044-4210-9932-f58b40bf68ac | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198014 | naproxen 500 MG Oral Tablet | PSN | 2077556d-29f3-469e-8fab-1d9dc7820b6d | 1 |
| 198014 | naproxen 500 MG Oral Tablet | SCD | 2077556d-29f3-469e-8fab-1d9dc7820b6d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66336-815-30 | 66336081530 | 30 in 1 BOTTLE | Historical |
| 66336-815-60 | 66336081560 | 60 in 1 BOTTLE | Historical |