NDC 0121-1053 - leuprolide acetate
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
- 0121-1053
- Package NDCs from labels
- 0121-1053-02
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Effective date
- 2026-01-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| leuprolide acetate - PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba PAI Pharma | 2026-01-16 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-1053-02 | leuprolide acetate | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 5 mg in 1mL | 4 |
| 0121-1053-02 | leuprolide acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 5 mg in 1mL | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | a480e5f4-5f9e-4b23-b257-b0ac1ebfc115 | 2025-01-07 | Warnings | Q40Q9N063P LKG8494WBH |
| Signature Care Alcohol Prep Pad | ISOPROPYL ALCOHOL | Better Living Brands LLC | adc87331-1aa1-3457-e053-2a95a90a7eb1 | 2025-01-03 | Warnings | 797544 ND2M416302 |
| Alcohol Extra-Thick | ISOPROPYL ALCOHOL | Meijer Distribution Inc | 0b02643d-ea14-4877-ae9c-f0749d1b2d10 | 2025-01-03 | Warnings | 797544 ND2M416302 |
| Premier Value | ISOPROPYL ALCOHOL | Pharmacy Value Alliance, LLC | d2baa47e-9673-7f23-e053-2a95a90adcb7 | 2025-01-03 | Warnings | 797544 ND2M416302 |
| CVS Alcohol Prep | ISOPROPYL ALCOHOL | CVS Pharmacy | 88f761c1-cb50-4edc-9a54-43444378eff7 | 2025-01-03 | Warnings | 797544 ND2M416302 |
| Sterile Alcohol | ISOPROPYL ALCOHOL | Chain Drug Marketing Association Inc | 55922632-3768-4450-9389-ba7d7d91f2c9 | 2025-01-03 | Warnings | 797544 ND2M416302 |
| Shingles Remedy | CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA | Silver Star Brands | 5d65c997-f5dc-4dee-e053-2a91aa0ac319 | 2025-01-01 | Warnings | 451W47IQ8X |
| Mucus Clear Allergy Relief | ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA | Silver Star Brands | f49bdcc1-1939-6dc2-e053-2995a90a0a3b | 2025-01-01 | Warnings | 451W47IQ8X |
| Sweat-Less | ARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MUR | Silver Star Brands | 4053d10b-4b06-291b-e054-00144ff88e88 | 2025-01-01 | Warnings | 451W47IQ8X |
| NativeRemedies Triple Complex Brain Tonic | CALC PHOS, KALI PHOS, NAT MUR. | Silver Star Brands | f76eaf46-4a80-31a9-e053-6394a90a542d | 2025-01-01 | Warnings | 451W47IQ8X |
| Headache Ease | AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA | Silver Star Brands | c689fb16-6200-ac94-e053-2995a90a703d | 2025-01-01 | Warnings | 451W47IQ8X |
| AllergiClear-M | ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA | Silver Star Brands | 9d36096b-022f-5cfa-e053-2995a90a381f | 2025-01-01 | Warnings | 451W47IQ8X |
| ALCOHOL PREP PADS MEDIUM STERILE | ISOPROPYL ALCOHOL CLOTH | JINHUA JINGDI MEDICAL SUPPLIES CO., LTD | 303097a0-8eb0-3e1c-e063-6394a90afab3 | 2025-01-01 | Warnings | 797544 ND2M416302 |
| BL-C Kit | BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE | Asclemed USA, Inc. | 798f3bc6-d976-49a6-87a2-fd30c784fc50 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| Pain Relieving Cream Lidocaine | BENZYL ALCOHOL, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 039a2036-54b2-cf28-e063-6294a90a8ce6 | 2024-12-31 | Warnings | LKG8494WBH |
| DG Health Sterile Saline Mist | SODIUM CHLORIDE | DG Health | f2e44ab4-ae0f-c87b-e053-2a95a90acd04 | 2024-12-31 | Warnings | 451W47IQ8X |
| Ketorocaine LM Kit | KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb81d452-30e0-f019-e053-6394a90a7634 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| Multi-Specialty Kit | DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL | Advanced Rx Pharmacy of Tennessee, LLC | fb85b480-d0cd-2539-e053-6294a90a5083 | 2024-12-31 | Warnings, Adverse reactions | 797544 |
| DoubleDex Kit | DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb85dd2c-6c90-6249-e053-6294a90a09fa | 2024-12-31 | Warnings, Adverse reactions | 797544 |
| Betalido Kit | BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb5d3ec8-8866-881d-e053-6294a90a1cc5 | 2024-12-31 | Warnings, Adverse reactions | 797544 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.