NDC 69809-0127-05 - Clozaril
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
- 69809-0127
- Requested NDC
- 69809-0127-05
- Package NDCs from labels
- 69809-0127-5, 69809-0127-05
- Manufacturer
- HLS Therapeutics (USA), Inc.
- Effective date
- 2025-06-06
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Clozaril - HLS Therapeutics (USA), Inc. | HLS Therapeutics (USA), Inc. | 2025-06-06 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69809-0127-5 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3629-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL ® (clozapine) tablets, for oral use Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69809-0127-5 | Clozaril | 100 in 1 BOTTLE | TABLET | 100 | 21 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69809-0127 | CLOZARIL (CLOZAPINE) TABLET [HLS THERAPEUTICS (USA), INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20250327_90876802-0e3a-44c9-9ff7-1754dfbe736a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69809-0127-5 | EA - Each | 69809-0127 | 80065849-bd3c-45fe-81e7-b6acd1b9c5be | 1 | 2017-07-07 |
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 |
|---|---|---|---|---|---|---|
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 9b4276af-b738-3293-e053-2a95a90ad022 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Clozapine | CLOZAPINE | Mylan Pharmaceuticals Inc. | 9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219 | 2025-08-15 | Boxed warning, Warnings, Adverse reactions | J60AR2IKIC |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 617303f8-4463-4a1e-a502-44abc181d91f | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 03153d92-dc68-4b84-a8c9-634b1ffd7da1 | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Cloveden Vegan Whitening Tooth | SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE | Acuseplanet Inc | 3c04778b-9535-856e-e063-6294a90aa868 | 2025-08-10 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Silica Cleanser and Conditioner 12 | SILICEA | Martin & Pleasance Pty Ltd | f70dcf90-bde9-404d-9ede-4113553ccbff | 2025-08-04 | Warnings | ETJ7Z6XBU4 |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 985a3341-0fe0-1dd6-e053-2a95a90ad2c5 | 2025-07-25 | Warnings | ETJ7Z6XBU4 |
| Dairy-Grain-Nightshade | IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE. | Newton Laboratories, Inc. | 99fcbd61-ecc8-cf9d-e053-2995a90aebeb | 2025-07-25 | Warnings | J2B2A4N98G |
| SILICA MARINA | SILICON DIOXIDE | Boiron | 3aada26e-6a8e-f545-e063-6394a90a9f80 | 2025-07-24 | ETJ7Z6XBU4 | |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1b4e96-c96f-6424-e053-2991aa0aef30 | 2025-07-24 | Warnings | ETJ7Z6XBU4 |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1a9ef9-9a54-5f94-e053-2a91aa0ab477 | 2025-07-24 | Warnings | ETJ7Z6XBU4 |
| Clozapine | CLOZAPINE | Mylan Institutional Inc. | 976be6e3-a9db-49c6-9b02-1ab168cf17b1 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | J60AR2IKIC |
| Aller-Chord F | ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE. | Energetix Corporation | ff4eb7b2-8272-4bd3-99a9-7e589b30d59a | 2025-07-15 | Warnings | ETJ7Z6XBU4 |
| DENTAL-CHORD | ACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUM | Energetix Corporation | 6c9ba926-7c35-49fd-94d8-988ca0bb772c | 2025-07-15 | Warnings | ETJ7Z6XBU4 |
| Endocrinpath | ALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corporation | 70f84941-b8a1-48f4-9c05-554e554f0049 | 2025-07-11 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12 | SILICEA | Martin & Pleasance Pty Ltd | 39620db9-5099-47f0-93ad-c00e6625c462 | 2025-07-07 | Warnings | ETJ7Z6XBU4 |
| Arnica Calendula Wound | ARNICA CALENDULA WOUND | Uriel Pharmacy, Inc | 38cfd292-4dbd-2caf-e063-6394a90a0527 | 2025-06-30 | Warnings | ETJ7Z6XBU4 |
| Bac | APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDE | Zorex | 7ae38e0c-8e74-4fd5-8605-45e424a84d01 | 2025-06-30 | Warnings | ETJ7Z6XBU4 |
| Bambusa Aurum | BAMBUSA AURUM | Uriel Pharmacy Inc. | 43f3dd30-701f-4fa4-9743-d10051c6e6d4 | 2025-06-27 | Warnings | ETJ7Z6XBU4 |
| Steritalc 2g | TALC | Novatech SA | c94e51d9-beef-4b06-e053-2a95a90a754a | 2025-06-25 | Warnings, Adverse reactions | 7SEV7J4R1U |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.