Application 019185
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | OXYTOCIN | INJECTABLE;INJECTION | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | OXYTOCIN | INJECTABLE;INJECTION | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | INJECTABLE;INJECTION | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | INJECTABLE;INJECTION | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | |
| N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | |
| N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | |
| N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019185-001 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019185-002 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019185-003 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019185-004 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-03-29 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Oxytocin | OXYTOCIN | REMEDYREPACK INC. | b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242 | 2026-09-01 | Warnings, Adverse reactions | OXYTOCIN |
| Pitocin | OXYTOCIN | Par Health USA, LLC | 6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | OXYTOCIN |
| Pitocin | OXYTOCIN | Par Health USA, LLC | 969d5b35-0add-4c23-9605-6a5b6ab65c95 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | OXYTOCIN |
| Pitocin | OXYTOCIN | Par Health USA, LLC | 6e5a66fc-e507-497c-b5ce-44a8c95898ad | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | OXYTOCIN |
| Oxytocin | OXYTOCIN | Fresenius Kabi USA, LLC | c7fd585a-99b7-4309-b003-a6cbef05372c | 2026-01-12 | Warnings, Adverse reactions | OXYTOCIN |
| Oxytocin | OXYTOCIN | Cardinal Health 107, LLC | 18fe8365-86e3-414e-84dc-c98e097a2f36 | 2025-06-20 | Warnings, Adverse reactions | OXYTOCIN |
| Oxytocin | OXYTOCIN | Fresenius Kabi USA, LLC | 4c4c4b69-8bf7-472c-aafe-29805ba5c965 | 2025-03-24 | Warnings, Adverse reactions | OXYTOCIN |
| Oxytocin | OXYTOCIN | Fresenius Kabi USA, LLC | 6d7d1280-f286-4f39-89f3-2b96571810e6 | 2024-10-15 | Warnings, Adverse reactions | OXYTOCIN |
| Pitocin | OXYTOCIN | Par Health USA, LLC | dddcdcc3-cd4d-4573-98ac-9468bea23a8b | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | OXYTOCIN |
| Oxytocin | OXYTOCIN | West-Ward Pharmaceuticals Corp | d16a48c5-6b71-40a0-bcda-204f043fe832 | 2018-12-14 | Boxed warning, Warnings, Adverse reactions | OXYTOCIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.