NDC 0409-1463-69 - Nalbuphine Hydrochloride
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
- 0409-1463
- Requested NDC
- 0409-1463-69
- Package NDCs from labels
- 0409-1463-69, 0409-1463-49, 0409-1463-71, 0409-1463-01
- Manufacturer
- Hospira, Inc.
- Effective date
- 2026-07-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nalbuphine Hydrochloride - Hospira, Inc. | Hospira, Inc. | 2026-07-16 | HUMAN PRESCRIPTION DRUG LABEL |
| NALBUPHINE HYDROCHLORIDE | Hospira, Inc. | 2025-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Nalbuphine Hydrochloride 10 mg Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 2025-05-21 | HUMAN PRESCRIPTION DRUG LABEL |
| Nalbuphine Hydrochloride - General Injectables & Vaccines, Inc | General Injectables & Vaccines, Inc | 2022-12-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-1463-01 | Nalbuphine Hydrochloride | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 34 | |
| 0409-1463-71 | Nalbuphine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | 34 | |
| 0409-1463-49 | Nalbuphine Hydrochloride | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 22 | |
| 0409-1463-69 | Nalbuphine Hydrochloride | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | 22 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0409-1463 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 33 | Current NDC, Legacy NDC, 2 package rows | 20241207_6025e8d4-5083-4c3a-58a0-050e7b0b6150.zip |
| 0409-1463 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241207_a99fe500-f52b-483c-807c-178f1a78a02b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1463-01 | ML - Milliliter | 0409-1463 | f5ce227b-79c3-421e-87ab-c2cc4f7b61af | 1 | 2012-07-24 |
| 0409-1463-49 | ML - Milliliter | 0409-1463 | 0aad1e9f-7b50-48dd-817d-2e77cfcbbbe9 | 1 | 2012-07-24 |
| 0409-1463-61 | ML - Milliliter | 0409-1463 | fe48bc7a-5c03-47c9-92e7-e4274395987f | 1 | 2012-07-24 |
| 0409-1463-69 | ML - Milliliter | 0409-1463 | c78083a0-9b54-4383-9449-72f915a3e619 | 1 | 2020-02-13 |
| 0409-1463-71 | ML - Milliliter | 0409-1463 | cce1a6c4-052d-43b3-b6bc-19f43a235f76 | 1 | 2020-03-10 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Metabatone | ARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM, | Energique, Inc. | 9510bb76-b717-407d-b9e8-da7743e4cfc8 | 2026-07-31 | Warnings | 451W47IQ8X |
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Bioplasma | SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE | Hyland's Inc. | dd0a7ed2-d112-4b96-e053-2995a90ac6b6 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 167c7a9c-1228-4fb2-a89c-d3e148386323 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline Solution Sodium Chloride | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 750ea4b1-de2b-4299-aaa2-331daf383d0d | 2026-07-30 | Warnings | 451W47IQ8X |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Delflex | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | a98facd6-9daa-4d37-8209-63a0599dbfaa | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | 9a1220fb-6853-45ae-838c-10d8596e1af7 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | af5cdf1a-19f4-11e2-892e-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 19daf830-7270-4661-81b1-ded38f867f28 | 2026-07-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Xenleta | LEFAMULIN ACETATE | Meitheal Pharmaceuticals Inc. | eb972ea8-7502-422e-84bb-66cb8e93ca06 | 2026-07-22 | Warnings, Adverse reactions | XF417D3PSL |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| Whisidom Saline Solution | SODIUM CHLORIDE 0.9% SALINE SOLUTION | Jiangxi Yudexi Pharmaceutical Co., LTD | 4e4e4169-2a14-3466-e063-6394a90a081b | 2026-07-20 | Warnings | 451W47IQ8X |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | 451W47IQ8X |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Hospira, Inc. | a99fe500-f52b-483c-807c-178f1a78a02b | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | ANDA070914 0409-1463-49 0409-1463-69 0409-1463 00409146369 1866543 8b279fac-ba78-4d94-be80-f515c4137896 a99fe500-f52b-483c-807c-178f1a78a02b ZU4275277R |
| Sodium Chloride | SODIUM CHLORIDE | LABORATORIOS GRIFOLS SA | eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf | 2026-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
| WHWSWB 0.9% SALINE | SODIUM CHLORIDE | Yiwu Huanshu E-commerce Co., Ltd | 5082b773-79b2-2501-e063-6394a90a170f | 2026-07-11 | Warnings | 451W47IQ8X |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | 451W47IQ8X |
| Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) | NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE) | Reedfresh Co., LTD | 55d703ca-ff9d-0dbc-e063-6294a90ab6b1 | 2026-07-05 | Warnings | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Protective Industrial Products, Inc. | 558e5926-9027-d3f6-e063-6294a90ab121 | 2026-07-02 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.