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 01:13:26
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-346-60 | EA - Each | 50458-346 | 1663bfb4-d20c-4a6e-9cd8-c0ba29490182 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50458-346 | 50458-346-60 |
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 | N022523-001 | PANCREAZE | 24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-002 | PANCREAZE | 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-003 | PANCREAZE | 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-004 | PANCREAZE | 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | PANCREAZE | 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2014-03-07 | 74a2ff9319b5… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-001 | PANCREAZE | 24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-002 | PANCREAZE | 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-003 | PANCREAZE | 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2010-04-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-004 | PANCREAZE | 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | PANCREAZE | 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2014-03-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-001 | PANCREAZE | 24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-002 | PANCREAZE | 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-003 | PANCREAZE | 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2010-04-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-004 | PANCREAZE | 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | PANCREAZE | 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2014-03-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-001 | PANCREAZE | 24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-002 | PANCREAZE | 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-003 | PANCREAZE | 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2010-04-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-004 | PANCREAZE | 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2010-04-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | PANCREAZE | 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2014-03-07 | ea99ee380514… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | 8221747 | 2028-02-20 | Drug product | 2017-12-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | 8562978 | 2028-02-20 | Drug product | 2017-12-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | 8562979 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | 8562980 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022523-005 | 8562981 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | 8221747 | 2028-02-20 | Drug product | 2017-12-07 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | 8562978 | 2028-02-20 | Drug product | 2017-12-07 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | 8562979 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | 8562980 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022523-005 | 8562981 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | 8221747 | 2028-02-20 | Drug product | 2017-12-07 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | 8562978 | 2028-02-20 | Drug product | 2017-12-07 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | 8562979 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | 8562980 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022523-005 | 8562981 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | 8221747 | 2028-02-20 | Drug product | 2017-12-07 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | 8562978 | 2028-02-20 | Drug product | 2017-12-07 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | 8562979 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | 8562980 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022523-005 | 8562981 | 2028-02-20 | U-1274 | Drug product | 2017-12-07 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.