Octreotide acetate
- Product NDC
- 64679-636
- 11-digit product format
- 646790636
- Labeler code
- 64679
- Product ID
- 64679-636_ef0b005f-898a-4944-a983-72fe170ab7c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Octreotide acetate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Wockhardt USA LLC.
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 64679-636 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 64679-636 | 64679-636-01 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 64679-636 | 64679-636-02 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 64679-636-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 64679-636-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 64679-636-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 64679-636-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 64679-636-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 64679-636-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 64679-636-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 64679-636-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 64679-636-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 64679-636-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 64679-636-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 64679-636-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 64679-636-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 64679-636-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 64679-636-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 64679-636-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 64679-636-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 64679-636-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64679-636-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64679-636-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64679-636-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64679-636-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64679-636-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64679-636-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 64679-636-02 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 64679-636-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 64679-636-02 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 64679-636-01 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 64679-636-02 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 64679-636-01 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 64679-636-01 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 64679-636-02 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 64679-636-01 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 64679-636-02 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 64679-636-01 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 64679-636-02 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 64679-636-01 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 64679-636-02 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 64679-636-01 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 64679-636-02 | e2bbac7714bc… | 27bdfed8d636… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | ||
| A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | ||
| A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 |
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 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090985-002 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.1MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090985-003 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.5MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090985-001 | OCTREOTIDE ACETATE PRESERVATIVE FREE | EQ 0.05MG BASE/ML | INJECTABLE / INJECTION | 2011-05-11 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|
| 64679-636-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb48-f424-e053-dadaa90a57ce | Octreotide Acetate Injection |
| 64679-636-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb48-f424-e053-dadaa90a57ce | Octreotide Acetate Injection |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64679-636-01 | Octreotide acetate | 1 mL in 1 VIAL | INJECTION | 1 | 1 | |
| 64679-636-01 | Octreotide acetate | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 64679-636-02 | Octreotide acetate | 1 mL in 1 VIAL | INJECTION | 1 | 1 | |
| 64679-636-02 | Octreotide acetate | 10 in 1 CARTON | INJECTION | 10 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | ACTIVE INGREDIENT | 75R0U2568I | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| OCTREOTIDE | ACTIVE MOIETY | RWM8CCW8GP | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OCTREOTIDE ACETATE INJECTION [WOCKHARDT USA LLC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312071 | octreotide 1000 MCG/ML Injectable Solution | PSN | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 314152 | octreotide 200 MCG/ML Injectable Solution | PSN | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312068 | octreotide 50 MCG in 1 ML Injection | PSN | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312068 | 1 ML octreotide 0.05 MG/ML Injection | SCD | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 314152 | octreotide 0.2 MG/ML Injectable Solution | SCD | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312071 | octreotide 1 MG/ML Injectable Solution | SCD | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312071 | octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 314152 | octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312068 | octreotide 50 MCG per 1 ML Injection | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | 5d3095a8-e5c7-4705-8c4f-9fca8afd5847 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 64679-636-01 | 64679063601 | 1 mL in 1 VIAL | 1 ml | Historical |
| 64679-636-02 | 64679063602 | 1 mL in 1 VIAL | 1 ml | Historical |