NDC 68788-9138-01 - Orphenadrine Citrate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68788-9138
- Requested NDC
- 68788-9138-01
- Package NDCs from labels
- 68788-9138-4, 68788-9138-2, 68788-9138-3, 68788-9138-6, 68788-9138-9, 68788-9138-1, 68788-9138-8, 68788-9138-01
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2026-08-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Orphenadrine Citrate Extended-Release Tablets Rx Only | Preferred Pharmaceuticals, Inc. | 2026-08-07 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-9138-1 | Orphenadrine Citrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 13 | |
| 68788-9138-2 | Orphenadrine Citrate | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | 13 | |
| 68788-9138-3 | Orphenadrine Citrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 13 | |
| 68788-9138-4 | Orphenadrine Citrate | 14 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 14 | 13 | |
| 68788-9138-6 | Orphenadrine Citrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 13 | |
| 68788-9138-8 | Orphenadrine Citrate | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 13 | |
| 68788-9138-9 | Orphenadrine Citrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-9138 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 7 package rows | 20240726_8ca9438d-320f-4499-aee7-6b8ca7cccc65.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Northwind Health Company, LLC | 106be130-b4f8-5ca1-e063-6294a90a1590 | 2026-01-01 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| Norgesic Forte | ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE | Poly Pharmaceuticals, Inc. | 85a3b808-b476-f2f0-e053-2a91aa0af21f | 2025-12-30 | Warnings, Adverse reactions | X0A40N8I4S |
| Discount Drug Mart Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Discount Drug Mart | f7fd53be-e501-d97f-e053-6394a90ad409 | 2025-12-30 | Warnings | 3NXW29V3WO |
| Exchange Select Artificial Tears Lubricant Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Army and Air Force Exchange Service | 9e478343-8ae7-823e-e053-2995a90a84ed | 2025-12-30 | Warnings | 3NXW29V3WO |
| DG Health Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400 | Dolgencorp LLC | 9cb20c3b-bf6d-8c7c-e053-2995a90aa485 | 2025-12-30 | Warnings | 3NXW29V3WO |
| Core Values Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Liberty Procurement Co. Inc. | f8285f68-c40c-19a8-e053-6394a90aacad | 2025-12-30 | Warnings | 3NXW29V3WO |
| Harris Teeter Eye Drops Artificial Tears | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Harris Teeter, LLC. | f82957d9-c4ad-a914-e053-6294a90aac50 | 2025-12-30 | Warnings | 3NXW29V3WO |
| CVS Gentle Tears | DEXTRAN 70, HYPROMELLOSE | CVS Pharmacy, Inc. | 9b1ea0eb-c34f-6603-e053-2995a90a6a95 | 2025-12-30 | Warnings | 3NXW29V3WO |
| Artificial Tears | GLYCERIN | Geri-Care Pharmaceuticals, Corp | 7cc437e3-bad9-59be-e053-2991aa0a1da3 | 2025-12-19 | Warnings | 3NXW29V3WO |
| Artificial Tears | GLYCERIN | NuCare Pharmaceuticals,Inc. | 97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d | 2025-12-15 | Warnings | 3NXW29V3WO |
| Orphenadrine Citrate, Aspirin and Caffeine | ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE | Atland Pharmaceuticals, LLC | 7776aae6-3cbd-4aed-9aac-4bed80339e27 | 2025-10-17 | Warnings, Adverse reactions | X0A40N8I4S |
| ORPHENGESIC FORTE | ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE | Galt Pharmaceuticals, LLC | 5bc485db-9d96-4291-aaa3-2a96ebf3098a | 2025-10-16 | Warnings, Adverse reactions | X0A40N8I4S |
| Orphenadrine Citrate, Aspirin and Caffeine | ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE | Atland Pharmaceuticals, LLC | 61ca2af1-081c-411c-90ce-ec6d9e3157b2 | 2025-10-16 | Warnings, Adverse reactions | X0A40N8I4S |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Lupin Pharmaceuticals, Inc. | 7b76c8a7-dd0c-481c-8299-26dfd38ce066 | 2025-09-10 | Warnings, Adverse reactions | ANDA040284 43386-480 994521 e80ecc89-bd45-4796-850b-c379a79ac7ab 7b76c8a7-dd0c-481c-8299-26dfd38ce066 X0A40N8I4S |
| Orphenadrine Citrate ER | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | b5a6846a-ebb3-1fdd-e053-2a95a90a4130 | 2024-12-31 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | fc63d413-39bd-409d-e053-6294a90a1463 | 2024-12-31 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Lake Erie Medical DBA Quality Care Products LLC | 233915f1-7d58-4b4c-a2bb-e73179d61d07 | 2024-12-16 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| Advanced Eye Relief/ Redness Maximum Relief | NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE | Bausch & Lomb Incorporated | 3c11285a-7e86-4b47-b1ee-e7d59858087d | 2024-09-25 | Warnings | 3NXW29V3WO |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Bryant Ranch Prepack | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 2024-08-27 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | NuCare Pharmaceuticals, Inc. | 3eb1b1cc-ed7a-6f0f-e054-00144ff88e88 | 2024-08-13 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.