NDC 71225-126-01 - DEXMEDETOMIDINE HYDROCHLORIDE
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
- 71225-126
- Requested NDC
- 71225-126-01
- Package NDCs from labels
- 71225-126-02, 71225-126-05, 71225-126-03, 71225-126-06, 71225-126-01, 71225-126-04
- Manufacturer
- Slayback Pharma LLC | Corden Pharma SpA
- Effective date
- 2024-12-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE - Slayback Pharma LLC | Corden Pharma SpA | Slayback Pharma LLC | Corden Pharma SpA | 2024-12-12 | Human Prescription Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71225-126-01 | DEXMEDETOMIDINE HYDROCHLORIDE | 20 mL in 1 VIAL | INJECTION | 20 | 10 | |
| 71225-126-02 | DEXMEDETOMIDINE HYDROCHLORIDE | 50 mL in 1 BOTTLE | INJECTION | 50 | 10 | |
| 71225-126-03 | DEXMEDETOMIDINE HYDROCHLORIDE | 100 mL in 1 BOTTLE | INJECTION | 100 | 10 | |
| 71225-126-04 | DEXMEDETOMIDINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION | 10 | 10 | |
| 71225-126-05 | DEXMEDETOMIDINE HYDROCHLORIDE | 20 in 1 CARTON | INJECTION | 20 | 10 | |
| 71225-126-06 | DEXMEDETOMIDINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION | 10 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71225-126-02 | ML - Milliliter | 71225-126 | 14c0e938-bf9f-4e78-a481-c74d96394de4 | 1 | 2020-01-03 |
| 71225-126-03 | ML - Milliliter | 71225-126 | 139017dc-5564-490a-9dd4-5ce1f81ebc93 | 1 | 2020-01-03 |
| 71225-126-05 | ML - Milliliter | 71225-126 | ed3ee683-648d-4ae3-b002-7abb76f60404 | 1 | 2020-01-03 |
| 71225-126-06 | ML - Milliliter | 71225-126 | c8e2f3ab-fcab-4c14-ae1d-d65e9638adbb | 1 | 2020-01-03 |
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 |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | eb1ba463-ab42-4f49-9ebe-3ad5af108326 | 2026-05-28 | Warnings, Adverse reactions | 1718906 1718909 1018WH7F9I |
| Plegisol | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | 35a174f0-f0d7-4ec7-3f81-d3d572c059cf | 2026-05-27 | Warnings, Adverse reactions | 451W47IQ8X |
| TPN Electrolytes | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUS | Hospira, Inc. | c00817bc-7b62-4abe-0280-e7930eda3f94 | 2026-05-25 | Warnings, Adverse reactions | 451W47IQ8X |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | CIVICA, INC. | 1faf1ac8-ff9b-4ed9-b562-06dab971173a | 2026-05-22 | Warnings, Adverse reactions | ANDA212791 1718906 1718909 1018WH7F9I |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Hospira, Inc. | 87d6e9dc-fe3b-4593-ac9a-d7493d1959c7 | 2026-05-22 | Warnings, Adverse reactions | 059QF0KO0R |
| SALINE CLEANING | SODIUM CHLORIDE | Guangzhou Huanmei Cosmetics Co., Ltd. | 524f07cc-ddb9-dda5-e063-6394a90ac0a5 | 2026-05-21 | Warnings | 451W47IQ8X |
| PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | Henry Schein, Inc. | 9eb336de-5fa5-4b46-b40b-a7ca5a0864bd | 2026-05-21 | Warnings, Adverse reactions | 1018WH7F9I |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Gland Pharma Limited | f307de7e-a9ab-4734-abb7-66b4e112bc51 | 2026-05-20 | Warnings, Adverse reactions | 1718906 1718909 1018WH7F9I |
| Precedex | DEXMEDETOMIDINE HYDROCHLORIDE | Hospira, Inc. | 548a88c0-afda-427e-75ac-5af0cfa2224c | 2026-05-20 | Warnings, Adverse reactions | 1718906 1718909 1718900 1018WH7F9I |
| WHITENING SUNSCREENANTI WRINKLE | WHITENING SUNSCREENANTI WRINKLE | Shantou Oushiya Biotechnology Co.,Ltd | 524384e9-b3f8-4c13-e063-6394a90a8973 | 2026-05-20 | Warnings | 059QF0KO0R |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | Mylan Institutional LLC | f140de5a-f13d-46b4-a742-049c63e474f5 | 2026-05-20 | Warnings, Adverse reactions | 1718906 1718909 1018WH7F9I |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE | Amneal Pharmaceuticals LLC | 4df8cc35-fc80-4438-b982-9c4b7d17bad2 | 2026-05-19 | Warnings, Adverse reactions | 1718906 1718909 1018WH7F9I |
| Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | a2a964f7-c3ec-4dfb-e3a0-6d8136a80397 | 2026-05-19 | Warnings, Adverse reactions | 451W47IQ8X |
| Dexmedetomidine | DEXMEDETOMIDINE | Gland Pharma Limited | 714cc0d2-8a4c-40c0-8ef0-dcfde4c46989 | 2026-05-19 | Warnings, Adverse reactions | 1018WH7F9I |
| Dexmedetomidine | DEXMEDETOMIDINE | Mylan Institutional LLC | ebdfe2e8-30ca-4f18-935a-41bcbbce4937 | 2026-05-18 | Warnings, Adverse reactions | 1018WH7F9I |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | e5e7aa2f-3697-4747-9045-670ea2b13557 | 2026-05-14 | Warnings | 451W47IQ8X |
| NebuClear MD | SALINE | Blue Echo Care LLC | 3f85fe62-230f-b0f1-e063-6394a90a5cb8 | 2026-05-11 | Warnings | 451W47IQ8X |
| Acne Relief | BELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHUR | NaturalCare | 487b1373-b78c-4510-964a-6ab0fe781ff4 | 2026-05-08 | Warnings | 451W47IQ8X |
| Plenamine | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE | B. Braun Medical Inc. | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 2026-05-08 | Warnings, Adverse reactions | AE28F7PNPL |
| Migraine Relief | BELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS | The Magni Company | 79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d | 2026-05-07 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.