Octreotide
- Product NDC
- 63323-376
- 11-digit product format
- 633230376
- Labeler code
- 63323
- Product ID
- 63323-376_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OCTREOTIDE ACETATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077457
- Marketing category
- ANDA
- Marketing start
- 2006-03-14
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | |
| A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | |
| A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077457-001 | AP |
| A077457-002 | AP |
| A077457-003 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077457-001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | AP | 2006-02-10 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077457-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077457-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077457-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077457-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077457-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077457-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077457-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077457-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077457-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077457-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077457-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077457-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077457-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077457-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077457-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077457-001 | AP | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Octreotide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTREOTIDE ACETATE | 100 ug/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 75R0U2568I | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f278f0d8-4062-420a-97c3-3a8b88253a08 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-376-00 | Octreotide | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 9 | |
| 63323-376-01 | Octreotide | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 9 | |
| 63323-376-04 | Octreotide | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 6 | |
| 63323-376-41 | Octreotide | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-376-00 | ML - Milliliter | 63323-376 | 51d074e4-06a9-44dc-a446-26557b04ada9 | 1 | 2023-03-13 |
| 63323-376-01 | ML - Milliliter | 63323-376 | 32811785-7b28-4627-960a-da0581df10cc | 1 | 2013-02-13 |
| 63323-376-04 | ML - Milliliter | 63323-376 | b4593d3f-2e5d-43c9-8524-910446c0347d | 1 | 2014-08-01 |
| 63323-376-41 | ML - Milliliter | 63323-376 | 51911689-cd27-43be-b37a-453862e34b4d | 1 | 2022-03-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-376 | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240518_f278f0d8-4062-420a-97c3-3a8b88253a08.zip |
| 63323-376 | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240530_d6a9a800-889d-417f-b533-1913197d0022.zip |
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 |
|---|---|---|---|---|---|---|
| Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | d6a9a800-889d-417f-b533-1913197d0022 | 2024-05-23 | Warnings, Adverse reactions | 077457 ANDA077457 63323-376 |
| Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | f278f0d8-4062-420a-97c3-3a8b88253a08 | 2024-05-07 | Warnings, Adverse reactions | 077457 ANDA077457 63323-376 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312071 | octreotide 1000 MCG/ML Injectable Solution | PSN | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 314152 | octreotide 200 MCG/ML Injectable Solution | PSN | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 314152 | octreotide 0.2 MG/ML Injectable Solution | SCD | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312071 | octreotide 1 MG/ML Injectable Solution | SCD | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312071 | octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 314152 | octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | f278f0d8-4062-420a-97c3-3a8b88253a08 | 9 |
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | d6a9a800-889d-417f-b533-1913197d0022 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-376-00 | 63323037600 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical | ||||
| 63323-376-01 | 63323037601 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-00) | 2006-03-14 | 0000-00-00 | No | No | Current | |
| 63323-376-04 | 63323037604 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-04) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-41) | 2006-03-14 | 0000-00-00 | No | No | Current | |
| 63323-376-41 | 63323037641 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical |