Naproxen
- Product NDC
- 21695-086
- 11-digit product format
- 216950086
- Labeler code
- 21695
- Product ID
- 21695-086_a04bcc67-1f1a-4669-bb69-77738a939944
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA075927
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- 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 |
|---|---|---|---|---|---|
| 21695-086-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-40 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
| 21695-086-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48b4-48b1-e053-8cdaa90a720a | Naproxen Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-086-14 | Naproxen | 14 in 1 BOTTLE | TABLET | 14 | 3 | |
| 21695-086-15 | Naproxen | 15 in 1 BOTTLE | TABLET | 15 | 3 | |
| 21695-086-20 | Naproxen | 20 in 1 BOTTLE | TABLET | 20 | 3 | |
| 21695-086-28 | Naproxen | 28 in 1 BOTTLE | TABLET | 28 | 3 | |
| 21695-086-30 | Naproxen | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 21695-086-40 | Naproxen | 40 in 1 BOTTLE | TABLET | 40 | 3 | |
| 21695-086-45 | Naproxen | 45 in 1 BOTTLE | TABLET | 45 | 3 | |
| 21695-086-60 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 21695-086-90 | Naproxen | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-086-14 | EA - Each | 21695-086 | fa9d37b6-ac32-450b-bbb3-851ab9e05250 | 1 | 2012-07-24 |
| 21695-086-15 | EA - Each | 21695-086 | be2cd16f-e413-4f10-a0ad-5228a7850b70 | 1 | 2012-07-24 |
| 21695-086-20 | EA - Each | 21695-086 | 6f780dd3-07ed-43e0-af79-37a52e1360b8 | 1 | 2012-07-24 |
| 21695-086-28 | EA - Each | 21695-086 | fee04739-0da7-411f-87ab-492e90d50901 | 1 | 2012-07-24 |
| 21695-086-30 | EA - Each | 21695-086 | 19dad0d5-1453-4b74-a393-f984c3ce36ee | 1 | 2012-07-24 |
| 21695-086-40 | EA - Each | 21695-086 | 5bb0cbb2-bb17-4001-9f19-1e2b03e7870e | 1 | 2012-07-24 |
| 21695-086-45 | EA - Each | 21695-086 | 49c65fa9-f481-4dfb-9947-c0899a0f0673 | 1 | 2012-07-24 |
| 21695-086-60 | EA - Each | 21695-086 | bbe58ff1-69c4-46eb-9190-f26a68dcd5b0 | 1 | 2012-07-24 |
| 21695-086-90 | EA - Each | 21695-086 | b8ce0211-6c9a-42dc-9d9e-ef84b40f6768 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.] | 3 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198013 | naproxen 250 MG Oral Tablet | PSN | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
| 198012 | naproxen 375 MG Oral Tablet | PSN | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
| 198014 | naproxen 500 MG Oral Tablet | PSN | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
| 198013 | naproxen 250 MG Oral Tablet | SCD | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
| 198012 | naproxen 375 MG Oral Tablet | SCD | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
| 198014 | naproxen 500 MG Oral Tablet | SCD | 8c7b265e-7500-464a-854e-9c4a22c8d211 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-086-14 | 21695008614 | 14 in 1 BOTTLE | Historical |
| 21695-086-15 | 21695008615 | 15 in 1 BOTTLE | Historical |
| 21695-086-20 | 21695008620 | 20 in 1 BOTTLE | Historical |
| 21695-086-28 | 21695008628 | 28 in 1 BOTTLE | Historical |
| 21695-086-30 | 21695008630 | 30 in 1 BOTTLE | Historical |
| 21695-086-40 | 21695008640 | 40 in 1 BOTTLE | Historical |
| 21695-086-45 | 21695008645 | 45 in 1 BOTTLE | Historical |
| 21695-086-60 | 21695008660 | 60 in 1 BOTTLE | Historical |
| 21695-086-90 | 21695008690 | 90 in 1 BOTTLE | Historical |