Norgesic Forte
- Product NDC
- 50991-999
- 11-digit product format
- 509910999
- Labeler code
- 50991
- Product ID
- 50991-999_472e3862-eab9-2279-e063-6394a90adb4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate, Aspirin and Caffeine
- Dosage form
- TABLET, MULTILAYER
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- ANDA075141
- Marketing category
- ANDA
- Marketing start
- 2019-04-01
- Substance
- ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
- Active strength
- 770; 60; 50 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norgesic Forte
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASPIRIN | 770 mg/1 |
| CAFFEINE | 60 mg/1 |
| ORPHENADRINE CITRATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R16CO5Y76E, 3G6A5W338E, X0A40N8I4S |
| Rxcui | 994535, 994537 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-999-06 | Norgesic Forte | 6 in 1 CARTON | TABLET, MULTILAYER | 6 | | 9 |
| 50991-999-60 | Norgesic Forte | 60 in 1 BOTTLE | TABLET, MULTILAYER | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-999 | NORGESIC FORTE (ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE) TABLET, MULTILAYER [POLY PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240128_85a3b808-b476-f2f0-e053-2a91aa0af21f.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 |
|---|
| 50991-999-06 | 50991099906 | 6 TABLET, MULTILAYER in 1 CARTON (50991-999-06) | 2022-03-28 | 0000-00-00 | No | No | Current |
| 50991-999-60 | 50991099960 | 60 TABLET, MULTILAYER in 1 BOTTLE (50991-999-60) | 2019-04-01 | 0000-00-00 | No | No | Current |