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 01:23:20
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53014-583-07 | EA - Each | 53014-583 | 273d379d-8a7a-4e1d-8eef-7f7dc8788532 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53014-583 | 53014-583-07 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021259-001 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 |
| N021259-002 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 |
| N021259-003 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 |
| N021259-004 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 |
| N021259-005 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 |
| N021259-006 | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021259-001 | AB2 |
| N021259-002 | AB2 |
| N021259-003 | AB2 |
| N021259-004 | AB2 |
| N021259-005 | AB2 |
| N021259-006 | AB2 |
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 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-005 | METADATE CD | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-006 | METADATE CD | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD, RS | 2006-02-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-001 | METADATE CD | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2001-04-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-002 | METADATE CD | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-06-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-003 | METADATE CD | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2003-05-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-004 | METADATE CD | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | RLD | 2006-02-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021259-001 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-002 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-003 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-004 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-005 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021259-006 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-004 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-005 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021259-006 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-005 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021259-006 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021259-006 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-005 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021259-006 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-004 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-005 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021259-006 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021259-004 | AB2 | 1 | b8a1b40f171c… |
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 | N021259-001 | 6344215 | 2020-10-27 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021259-002 | 6344215 | 2020-10-27 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021259-003 | 6344215 | 2020-10-27 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021259-004 | 6344215 | 2020-10-27 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021259-001 | 6344215 | 2020-10-27 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021259-002 | 6344215 | 2020-10-27 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021259-003 | 6344215 | 2020-10-27 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021259-004 | 6344215 | 2020-10-27 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021259-001 | 6344215 | 2020-10-27 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021259-002 | 6344215 | 2020-10-27 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021259-003 | 6344215 | 2020-10-27 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021259-004 | 6344215 | 2020-10-27 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021259-001 | 6344215 | 2020-10-27 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021259-002 | 6344215 | 2020-10-27 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021259-003 | 6344215 | 2020-10-27 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021259-004 | 6344215 | 2020-10-27 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021259-001 | 6344215 | 2020-10-27 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021259-002 | 6344215 | 2020-10-27 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021259-003 | 6344215 | 2020-10-27 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021259-004 | 6344215 | 2020-10-27 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021259-001 | 6344215 | 2020-10-27 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021259-002 | 6344215 | 2020-10-27 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021259-003 | 6344215 | 2020-10-27 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021259-004 | 6344215 | 2020-10-27 | Drug product | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.