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 |
|---|---|---|---|---|---|---|
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2b8220f-e33a-51c3-e053-2995a90a0734 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2bba76a-08ce-6902-e053-2995a90ab9c9 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Budesonide | BUDESONIDE | Teva Pharmaceuticals USA, Inc. | d90ffda1-12c7-4726-90e9-64bb103e84b5 | 2019-10-31 | Warnings, Adverse reactions | 252559 Q3OKS62Q6X |
| PULMICORT RESPULES | BUDESONIDE | AstraZeneca Pharmaceuticals LP | 33cd9834-76df-4f26-3fa2-aab6b9eee8f2 | 2019-10-11 | Warnings, Adverse reactions | 351109 252559 349094 Q3OKS62Q6X |
| Plasma-Lyte A | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | 6ec9e61c-2c26-402f-8604-f446b2e34058 | 2019-08-05 | Warnings, Adverse reactions | 451W47IQ8X |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | AstraZeneca Pharmaceuticals LP | fafa4cf1-99c2-43d5-73ad-51f256de3be0 | 2019-07-24 | Warnings, Adverse reactions | Q3OKS62Q6X |
| Budesonide and Formoterol Fumarate Dihydrate | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | AstraZeneca Pharmaceuticals LP | 1d266fe8-52e3-4f85-a037-c5c1afa15e60 | 2019-07-24 | Warnings, Adverse reactions | Q3OKS62Q6X |
| Potassium Chloride in Dextrose and Sodium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Baxter Healthcare Company | c553fed1-3de5-4826-8eff-633b5923bf0b | 2019-02-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Company | becc7410-0a25-49f5-b0c3-240078479dc8 | 2019-01-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | 451W47IQ8X |
| H.M.D. | ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM | Zorex International | 8c53091a-904d-4756-93e4-17143c5b48e9 | 2018-12-21 | Warnings | 451W47IQ8X |
| GUNA-ALLERGY-PREV | AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT - | Guna spa | adae93c0-1de9-4e45-ab58-148171f0dc86 | 2018-12-21 | Warnings | 2968PHW8QP |
| Vitality Female | ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Natural Creations, Inc | 679ba86d-bf84-4ded-b0bf-d55a0df9faa4 | 2018-12-21 | Warnings | 451W47IQ8X |
| Hydrate II | BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA | Zorex International | e5f53495-3b75-4d7c-89af-23058fb6fd05 | 2018-12-21 | Warnings | 451W47IQ8X |
| WinCo Foods Saline Nasal Relief | SODIUM CHLORIDE | WinCo Foods, LLC | 1280fee4-e763-49ba-8722-8cdb8157f1a4 | 2018-08-02 | Warnings | 451W47IQ8X |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 05dee566-7b82-4216-8a6b-765d2b4d9dc7 | 2018-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| HA HP | BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA | BioActive Nutritional, Inc. | 30f6c191-ce6e-438c-9601-74f5e8b61f96 | 2018-07-06 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.