NDC 0143-9366-01 - Labetalol HCl in Sodium Chloride
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
- 0143-9366
- Requested NDC
- 0143-9366-01
- Package NDCs from labels
- 0143-9366-01, 0143-9366-10
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Effective date
- 2025-12-19
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Labetalol HCl in Sodium Chloride - Hikma Pharmaceuticals USA Inc. | Hikma Pharmaceuticals USA Inc. | 2025-12-19 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9366-01 | Labetalol HCl in Dextrose | 200 mL in 1 BAG | INJECTION | 200 | 9 | |
| 0143-9366-10 | Labetalol HCl in Dextrose | 10 in 1 BOX | INJECTION | 10 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0143-9366 | LABETALOL HCL IN SODIUM CHLORIDE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HCL IN DEXTROSE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250131_99a715a0-4579-410c-b102-7ef6fab8db55.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9366-01 | ML - Milliliter | 0143-9366 | dc2c5df0-e7bd-4967-b443-84f81a0ef799 | 1 | 2021-05-05 |
| 0143-9366-10 | ML - Milliliter | 0143-9366 | 5f5ff719-8e9d-42b4-9c51-854907e51578 | 1 | 2021-05-05 |
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 |
|---|---|---|---|---|---|---|
| Labetalol hydrochloride | LABETALOL HYDROCHLORIDE | Proficient Rx LP | c0301841-e209-4242-bace-58a20e6dd01b | 2022-11-01 | Warnings, Adverse reactions | 1GEV3BAW9J |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 51da05ce-e3c4-4ef5-a845-dc869152e17f | 2022-10-24 | Warnings, Adverse reactions | 451W47IQ8X |
| LABETALOL HCl | LABETALOL HCL | HF Acquisition Co LLC, DBA HealthFirst | e76c4b37-4a34-249d-e053-2995a90aa9be | 2022-10-01 | Warnings, Adverse reactions | 1GEV3BAW9J |
| Dr Talbots Infant Daily Allergy Relief | ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e8bdcc8a-c947-ff5d-e053-2a95a90a3b92 | 2022-09-12 | Warnings | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | 6a1322c7-7767-4569-aa22-9d2e36331283 | 2022-08-30 | Warnings | 451W47IQ8X |
| Kids Cold and Cough Nighttime Grape Flavor | ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR | Hyland's Consumer Health Inc. | e676dbb7-212f-47e3-e053-2995a90af4e1 | 2022-08-17 | Warnings | 451W47IQ8X |
| Kids Cold and Cough Daytime Grape Flavor | ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR | Hyland's Consumer Health Inc. | e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d | 2022-08-16 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist PediaMeds | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5b580-1d9f-3081-e053-2995a90a8031 | 2022-08-08 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist SinuCleanse Breathe | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5c313-046f-b0a7-e053-2a95a90a2a07 | 2022-08-08 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 123bd10a-90c7-499e-97f6-acf7e0f0fb4e | 2022-07-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | fad9615f-7004-415d-9f69-ee9ff95f0067 | 2022-07-12 | Warnings | 451W47IQ8X |
| BHI Constipation | DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED | MediNatura Inc | 0365b75b-fee4-4c1d-89ab-c692bdd73f75 | 2022-07-07 | Warnings | 451W47IQ8X |
| Natrium Muriaticum 6X | SODIUM CHLORIDE | Seroyal USA | 0ebf18de-12fe-0bc4-e054-00144ff88e88 | 2022-07-07 | Warnings | 451W47IQ8X |
| Erogetone | ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Energique, Inc. | 1e872ecd-e7a5-463d-9832-47b7046096db | 2022-06-28 | Warnings | 451W47IQ8X |
| Cardioplegic Solution | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Fresenius Kabi, USA, LLC | eb360dc4-88d6-4b28-9b61-bc359e16bd22 | 2022-05-27 | Warnings, Adverse reactions | 451W47IQ8X |
| labetalol hydrochloride | LABETALOL HYDROCHLORIDE | Sagent Pharmaceuticals | da8af6c2-d822-4ae5-9c2d-a1d161bdefd0 | 2022-04-12 | Warnings, Adverse reactions | 1GEV3BAW9J |
| Miracle FootCream Lavender | UREA, GLYCERIN, ALOE, DISODIUM EDTA | Aloe Vera Korea Co.,Ltd. | db520c80-2a2a-5eb1-e053-2995a90a5bb4 | 2022-03-28 | Warnings | 7FLD91C86K |
| Miracle FootCream Lemon | UREA, GLYCERIN, ALOE, DISODIUM EDTA | Aloe Vera Korea Co.,Ltd. | db525c63-29fd-2033-e053-2995a90a56b9 | 2022-03-28 | Warnings | 7FLD91C86K |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.