Octreotide acetate
- Product NDC
- 55648-636
- 11-digit product format
- 556480636
- Labeler code
- 55648
- Product ID
- 55648-636_3612a4d7-791d-4f11-aab1-4aefb5203bf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Octreotide acetate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Wockhardt Limited
- Application
- ANDA090985
- Marketing category
- ANDA
- Marketing start
- 2011-05-11
- Marketing end
- 0000-00-00
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 50 ug/mL
- Pharmacologic classes
- Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 813db1d8-6534-4d2d-be9e-8d2c20a55eda | Product name | 1 | 20241217 |
| a6ddfef5-d553-2919-73fa-8aede2a8ab27 | Product name | 5 | 20240823 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 8f3fde6c-976e-4e4c-8ed4-542294fcc0ef | Product name | 1 | 20210115 |
| 467fba3a-c020-419e-8102-aeb9c0ea15ec | Product name | 1 | 20200616 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55648-636-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6751-f424-e053-dadaa90a57ce | Octreotide Acetate Injection |
| 55648-636-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6751-f424-e053-dadaa90a57ce | Octreotide Acetate Injection |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55648-636-01 | Octreotide acetate | 1 mL in 1 VIAL | INJECTION | 1 | 1 | |
| 55648-636-01 | Octreotide acetate | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 55648-636-02 | Octreotide acetate | 10 in 1 CARTON | INJECTION | 10 | 1 | |
| 55648-636-02 | Octreotide acetate | 1 mL in 1 VIAL | INJECTION | 1 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | ACTIVE INGREDIENT | 75R0U2568I | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| OCTREOTIDE | ACTIVE MOIETY | RWM8CCW8GP | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OCTREOTIDE ACETATE INJECTION [WOCKHARDT LIMITED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312071 | octreotide 1000 MCG/ML Injectable Solution | PSN | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 314152 | octreotide 200 MCG/ML Injectable Solution | PSN | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312068 | octreotide 50 MCG in 1 ML Injection | PSN | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312068 | 1 ML octreotide 0.05 MG/ML Injection | SCD | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 314152 | octreotide 0.2 MG/ML Injectable Solution | SCD | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312071 | octreotide 1 MG/ML Injectable Solution | SCD | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312071 | octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 314152 | octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312068 | octreotide 50 MCG per 1 ML Injection | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | dec280fa-6646-4cfe-916e-5f3485378050 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 55648-636-01 | 55648063601 | 1 mL in 1 VIAL | 1 ml | Historical |
| 55648-636-02 | 55648063602 | 10 in 1 CARTON | Historical |