National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 01:12:25
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55566-8505-2 | EA - Each | 55566-8505 | 141be804-2199-4676-b722-2c506c7dba08 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55566-8505 | 55566-8505-2 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021289-001 | BRAVELLE | 75 IU/VIAL | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2002-05-06 | 74a2ff9319b5… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021289-001 | BRAVELLE | 75 IU/VIAL | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2002-05-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021289-001 | BRAVELLE | 75 IU/VIAL | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2002-05-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021289-001 | BRAVELLE | 75 IU/VIAL | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2002-05-06 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.