NDC 69097-321-86 - Budesonide Inhalation Suspension
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
- 69097-321
- Requested NDC
- 69097-321-86
- Package NDCs from labels
- 69097-321-86, 69097-321-87, 69097-321-32, 69097-321-53
- Manufacturer
- Cipla USA Inc. | CIPLA LIMITED GOA | CIPLA LIMITED INDORE | Cipla (Jiangsu) Pharmaceutical Co., Ltd.
- Effective date
- 2026-06-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Budesonide Inhalation Suspension | Cipla USA Inc. | CIPLA LIMITED GOA | CIPLA LIMITED INDORE | Cipla (Jiangsu) Pharmaceutical Co., Ltd. | 2026-06-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69097-321-32 | BudesonideInhalation Suspension | 2 mL in 1 AMPULE | INHALANT | 2 | 12 | |
| 69097-321-32 | BudesonideInhalation Suspension | 1 in 1 POUCH | INHALANT | 1 | 12 | |
| 69097-321-53 | BudesonideInhalation Suspension | 30 in 1 CARTON | INHALANT | 30 | 12 | |
| 69097-321-86 | BudesonideInhalation Suspension | 2 mL in 1 AMPULE | INHALANT | 2 | 12 | |
| 69097-321-86 | BudesonideInhalation Suspension | 5 in 1 POUCH | INHALANT | 5 | 12 | |
| 69097-321-87 | BudesonideInhalation Suspension | 6 in 1 CARTON | INHALANT | 6 | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-321-32 | ML - Milliliter | 69097-321 | eb019ceb-9ce2-46b0-9a47-6b113aa8da20 | 1 | 2020-09-14 |
| 69097-321-53 | ML - Milliliter | 69097-321 | 1b6883a7-5982-4fc4-a3cd-a0fd2ce24e02 | 1 | 2020-08-06 |
| 69097-321-86 | ML - Milliliter | 69097-321 | f30aa7f6-bcf5-4a34-9751-2b2ef1f87e73 | 1 | 2018-03-08 |
| 69097-321-87 | ML - Milliliter | 69097-321 | 89a7705b-8a3c-4692-84a2-a467bc955649 | 1 | 2017-12-14 |
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 |
|---|---|---|---|---|---|---|
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5448c76a-2ecb-9402-e063-6294a90a6ad7 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 451W47IQ8X |
| Male Support | AGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 29cefc89-3bb6-484e-84ab-116b5827a4c3 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410ec88-8c65-3b26-e063-6294a90adf07 | 2026-06-12 | Warnings | 451W47IQ8X |
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Cardinal Health 107, LLC | b3d5225c-0ee4-481e-b9ec-bc5e1321096d | 2026-06-12 | Adverse reactions | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
| Budesonide Inhalation Suspension | BUDESONIDE | Cipla USA Inc. | c52c5382-1400-44b9-95be-a30e1cf706da | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ANDA205710 69097-321-32 69097-319-86 69097-321-87 69097-318-32 69097-319-53 69097-318-87 69097-319-87 69097-318-53 69097-318-86 69097-319-32 69097-321-86 69097-321-53 69097-318 69097-321 69097-319 69097032186 351109 252559 349094 29644146-4bcf-49d0-80b3-e31f4b3a6f54 c52c5382-1400-44b9-95be-a30e1cf706da Q3OKS62Q6X |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
| GUNA-ALLERGY T | AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA - | Guna spa | fddba85e-2bec-468f-a01a-b71a3aeed9d3 | 2026-06-10 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d2c34e-fa4d-9240-e063-6294a90a28da | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d48847-c0bf-1334-e063-6294a90acf7e | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53d52b7e-1e84-d4d3-e063-6294a90a9efc | 2026-06-09 | Warnings | 451W47IQ8X |
| Apizelen | GERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUM | BioActive Nutritional, Inc. | 471a7fab-1ef1-4d13-a28e-75f9762a711a | 2026-06-08 | Warnings | 451W47IQ8X |
| BM Nat Mur | NATRIUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53baa9ce-5ce6-7bba-e063-6294a90a517a | 2026-06-08 | Warnings | 451W47IQ8X |
| BM Nat Mur Icing Sugar | NATRUM MURIATICUM ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5356d350-1325-7299-e063-6294a90a96a0 | 2026-06-03 | Warnings | 451W47IQ8X |
| Plegisol | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | 35a174f0-f0d7-4ec7-3f81-d3d572c059cf | 2026-05-27 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.