Naproxen Headache Pain
- Product NDC
- 50844-471
- 11-digit product format
- 508440471
- Labeler code
- 50844
- Product ID
- 50844-471_831bfaae-6043-4bb8-9ca2-0ec4043040a7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA204872
- Marketing category
- ANDA
- Marketing start
- 2020-09-16
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Headache Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50844-471-11 | Naproxen Headache Pain | 60 in 1 CARTON | TABLET, FILM COATED | 60 | | 6 |
| 50844-471-14 | Naproxen Headache Pain | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 6 |
| 50844-471-16 | Naproxen Headache Pain | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 6 |
| 50844-471-19 | Naproxen Headache Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 50844-471-19 | Naproxen Headache Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | | 6 |
| 50844-471-22 | Naproxen Headache Pain | 48 in 1 CARTON | TABLET, FILM COATED | 48 | | 6 |
| 50844-471-43 | Naproxen Headache Pain | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 6 |
| 50844-471-56 | Naproxen Headache Pain | 25 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 25 | | 6 |
| 50844-471-98 | Naproxen Headache Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | | 6 |
| 50844-471-99 | Naproxen Headache Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-471 | NAPROXEN HEADACHE PAIN (NAPROXEN SODIUM) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 5 | Current NDC, Legacy NDC, 10 package rows | 20240628_6161b881-f422-47ae-86ba-a28d669bce79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-471-11 | 50844047111 | 60 POUCH in 1 CARTON (50844-471-11) / 1 TABLET, FILM COATED in 1 POUCH (50844-471-43) | 60 pouch | 2020-09-16 | | No | No | Current |
| 50844-471-14 | 50844047114 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-14) | | 2020-09-16 | 0000-00-00 | No | No | Current |
| 50844-471-16 | 50844047116 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-16) | | 2020-09-16 | 0000-00-00 | No | No | Current |
| 50844-471-19 | 50844047119 | 1 BOTTLE, PLASTIC in 1 CARTON (50844-471-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | | 2020-09-16 | 0000-00-00 | No | No | Current |
| 50844-471-22 | 50844047122 | 48 POUCH in 1 CARTON (50844-471-22) / 1 TABLET, FILM COATED in 1 POUCH (50844-471-43) | 48 pouch | 2020-09-16 | | No | No | Current |
| 50844-471-43 | 50844047143 | 1 in 1 POUCH | | | | | | Historical |
| 50844-471-56 | 50844047156 | 25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-56) | | 2020-09-16 | 0000-00-00 | No | No | Current |
| 50844-471-98 | 50844047198 | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-98) | | 2020-09-16 | 0000-00-00 | No | No | Current |
| 50844-471-99 | 50844047199 | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-99) | | 2020-09-16 | 0000-00-00 | No | No | Current |