NDC 0069-0400-01 - Zithromax
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
- 0069-0400
- Requested NDC
- 0069-0400-01
- Package NDCs from labels
- 0069-0400-01, 0069-0400-10
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Ireland Pharmaceuticals Unlimited Company
- Effective date
- 2026-09-09
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Zithromax | Pfizer Laboratories Div Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | 2026-09-09 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0069-0400-01 | Zithromax | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | 25 | |
| 0069-0400-10 | Zithromax | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0069-0400 | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 25 | Current NDC, Legacy NDC, 2 package rows | 20250212_8d24bacb-feff-4c6a-b8df-625e1435387a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-0400-01 | EA - Each | 0069-0400 | d7c08308-f15a-4aba-9d7c-7c2716a206c1 | 1 | 2014-04-03 |
| 0069-0400-10 | EA - Each | 0069-0400 | e0653e4e-6e09-4e11-a661-10801d9d44eb | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AZITHROMYCIN DIHYDRATE | ACTIVE INGREDIENT | 5FD1131I7S | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 |
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 |
|---|---|---|---|---|---|---|
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 94e17ae5-0871-67a0-e053-2995a90ae0ae | 2026-09-09 | Warnings, Adverse reactions | 5FD1131I7S |
| azithromycin | AZITHROMYCIN | REMEDYREPACK INC. | da399401-1ee6-422a-be46-0bba6b264b2f | 2026-09-08 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin | AZITHROMYCIN | Aurobindo Pharma Limited | 3c902990-b870-4725-b9fe-76b8be633e1c | 2026-09-03 | Warnings, Adverse reactions | 5FD1131I7S |
| azithromycin | AZITHROMYCIN | Major Pharmaceuticals | 814abe38-da4a-48af-bf4b-2ce04a5aabd1 | 2026-09-02 | Warnings, Adverse reactions | 5FD1131I7S |
| azithromycin | AZITHROMYCIN | REMEDYREPACK INC. | bf061799-cdef-40f8-b1ce-bc5eb609f8c3 | 2026-09-02 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin | AZITHROMYCIN | Aurobindo Pharma Limited | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 2026-09-02 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | REMEDYREPACK INC. | 0d5129e4-8b94-4a4d-baa9-be0d6b32d714 | 2026-08-31 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | REMEDYREPACK INC. | f0cfda1a-910f-4764-8658-263037df5ea8 | 2026-08-28 | Warnings, Adverse reactions | 5FD1131I7S |
| azithromycin | AZITHROMYCIN | Lupin Pharmaceuticals, Inc. | 01649d79-4677-4577-a3e4-e054f3f9fc3b | 2026-08-20 | Warnings, Adverse reactions | 5FD1131I7S |
| azithromycin | AZITHROMYCIN | Lupin Pharmaceuticals, Inc. | c9990a1d-5238-403e-9221-72a9314d7b5e | 2026-08-20 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin | AZITHROMYCIN | Zydus Pharmaceuticals USA Inc. | 99e5bd22-a721-4e2e-a46c-d61a53c25c3d | 2026-08-14 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin monohydrate | AZITHROMYCIN MONOHYDRATE | Gland Pharma Limited | 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3 | 2026-08-12 | Warnings, Adverse reactions | 1668238 |
| Adaptopath | ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM | Energetix Corporation | 41234598-0cb5-41c2-bfbe-1c15ee9bf502 | 2026-08-11 | Warnings | XF417D3PSL |
| Aller-Chord A | ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE | Energetix Corporation | 09e89c92-112d-4320-9df5-b9f938bb9095 | 2026-08-11 | Warnings | XF417D3PSL |
| Hepatic-Tone | CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALE | Energetix Corporation | d5f61f13-7e9f-4e46-8ad8-0336f36288df | 2026-08-11 | Warnings | XF417D3PSL |
| Isopathic Phenolic Rings | HOMEOPATHIC LIQUID | Energetix Corporation | 98a7ca26-ccb7-43c7-bd65-892fcbacc882 | 2026-08-11 | Warnings | XF417D3PSL |
| Metabopath | ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM, | Energetix Corporation | 58bfe670-d308-45a2-8046-7897b6221452 | 2026-08-11 | Warnings | XF417D3PSL |
| Azithromycin | AZITHROMYCIN | REMEDYREPACK INC. | 614cc2a4-3fc7-455d-9e8a-212c496f0fbf | 2026-08-05 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | REMEDYREPACK INC. | c7ed6985-1d1d-48af-9df8-64b12821789e | 2026-08-04 | Warnings, Adverse reactions | 5FD1131I7S |
| Azithromycin | AZITHROMYCIN | Sandoz Inc | 34b70c23-92a6-460f-8dbb-15a0e6b9d3a9 | 2026-07-30 | Warnings, Adverse reactions | 5FD1131I7S |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.