Anesthesia S/I-40
- Product NDC
- 49836-025
- 11-digit product format
- 498360025
- Labeler code
- 49836
- Product ID
- 49836-025_79b5d917-ebef-4771-a8b0-eb78c05ef8b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propofol, Isopropyl Alcohol
- Dosage form
- KIT
- Labeler
- RX PHARMA-PACK, INC.
- Application
- NDA019627
- Marketing category
- NDA
- Marketing start
- 2017-08-24
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49836-025 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 49836-025 | 49836-025-09 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019627-001 | DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | ||
| N019627-002 | DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019627-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N019627-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | e3105799-a4b6-f3f4-e6e2-b2b29bbdb538 | 2025-09-11 | Warnings, Adverse reactions | 019627 NDA019627 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | fee3bd4a-ade3-41fa-839a-48e9af69bcf4 | 2025-09-10 | Warnings, Adverse reactions | 019627 NDA019627 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | d1ae9e26-ffd6-43df-bbd6-869cdede6afe | 2025-04-21 | Warnings, Adverse reactions | 019627 NDA019627 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | ee0c3437-614d-4631-a061-257f5f60c70b | 2025-02-20 | Warnings, Adverse reactions | 019627 NDA019627 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | 5cec3b97-5183-4a9d-accd-21e76c99d3dd | 2024-04-18 | Warnings, Adverse reactions | 019627 NDA019627 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49836-025-09 | EA - Each | 49836-025 | 8510dab5-8c82-4ebc-a159-46d892ea8dbd | 1 | 2017-09-11 |