NDC 85534-0010-01 - Gabapentin
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
- 85534-0010
- Requested NDC
- 85534-0010-01
- Package NDCs from labels
- 85534-0010-0, 85534-0010-1, 85534-0010-2, 85534-0010-3, 85534-0010-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-02
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Gabapentin - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-07-02 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Gabapentin | GABAPENTIN | Proficient Rx LP | f651a143-3f88-49c9-b5c4-c9af55aea76a | 2022-10-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| Hendel Periodontal and Tooth Pain Relief | SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE | MediNatura Inc | f34e9f77-69fd-4c7f-9eea-2d721a4d27fb | 2022-08-22 | Warnings | ETJ7Z6XBU4 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 176c5b60-93c2-4574-8b51-c15180912aaa | 2022-08-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| Neurontin | GABAPENTIN | Parke-Davis Div of Pfizer Inc | ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388 | 2022-07-12 | Warnings, Adverse reactions | 310433 310434 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | 14b1840d-a2db-4eec-bc25-029e35b042e4 | 2022-07-09 | Warnings, Adverse reactions | 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | c18d9d06-f796-4eb7-8fd5-1de4ebb95439 | 2022-07-07 | Warnings, Adverse reactions | ANDA205101 310433 6CW7F3G59X |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | 15FIX9V2JP |
| GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 17988b64-723c-488d-befd-3e4e4cc44bd2 | 2022-05-11 | Warnings, Adverse reactions | 310434 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | ed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e | 2022-05-02 | Warnings, Adverse reactions | 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 645824d0-eb3d-442b-806d-36a70796cb8e | 2022-05-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | aa3ab216-372a-4a72-bfd1-88a1ffa31ba3 | 2022-05-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | b67b7865-df64-429a-9550-5333b9c713ea | 2022-04-01 | Warnings, Adverse reactions | ANDA205101 310433 310434 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 223a9216-6e07-49b9-8faf-bb4e529a6ae5 | 2022-04-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 2fb2233f-9152-4630-ab39-51a0cda7e5ca | 2022-04-01 | Warnings, Adverse reactions | ANDA205101 310433 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 52af51ab-6543-466b-848c-13c588c98789 | 2022-04-01 | Warnings, Adverse reactions | 6CW7F3G59X |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 2b76955c-52a4-4026-b286-3da1112fe989 | 2022-04-01 | Warnings, Adverse reactions | ANDA205101 310434 6CW7F3G59X |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe Mexico, S.A. de C.V. | 3e2e5f52-db54-4635-83a8-a67a683c093c | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe North America, Inc. | 94de9ce3-6ee9-4322-bda2-0b4391f09d87 | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 7790d906-af26-4e60-bc6f-e906ec03cc24 | 2022-03-21 | Warnings, Adverse reactions | 310433 6CW7F3G59X |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da807eb3-34a3-61b9-e053-2995a90a0e21 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.