Norgesic
- Product NDC
- 61825-305
- 11-digit product format
- 618250305
- Labeler code
- 61825
- Product ID
- 61825-305_47da9e12-c9c2-d80e-e063-6294a90a86aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate, Aspirin and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Galt Pharmaceuticals, LLC
- Application
- ANDA075141
- Marketing category
- ANDA
- Marketing start
- 2022-05-16
- Substance
- ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
- Active strength
- 385; 30; 25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Centrally-mediated Muscle Relaxation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Muscle Relaxant [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norgesic
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASPIRIN | 385 mg/1 |
| CAFFEINE | 30 mg/1 |
| ORPHENADRINE CITRATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R16CO5Y76E, 3G6A5W338E, X0A40N8I4S |
| Rxcui | 994528, 994530 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61825-305-60 | Norgesic | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61825-305 | NORGESIC (ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE) TABLET [GALT PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_be2761bc-e537-4039-846a-2ffa3d8b2afc.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 |
|---|
| 61825-305-60 | 61825030560 | 60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60) | 60 tablet | 2022-05-16 | 0000-00-00 | No | No | Current |