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 01:12:00
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0371-05 | EA - Each | 0078-0371 | 13653f30-ce56-4c71-87f4-10cdaa3feed9 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0078-0371 | 0078-0371-05 |
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 |
|---|---|---|---|---|---|---|---|
| N021284-001 | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 |
| N021284-002 | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 |
| N021284-003 | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 |
| N021284-004 | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 |
| N021284-005 | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021284-001 | AB1 |
| N021284-002 | AB1 |
| N021284-003 | AB1 |
| N021284-004 | AB1 |
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 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-001 | RITALIN LA | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-002 | RITALIN LA | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-003 | RITALIN LA | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-004 | RITALIN LA | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2004-04-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-005 | RITALIN LA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-10-27 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021284-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021284-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021284-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021284-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021284-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021284-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021284-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021284-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021284-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021284-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021284-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021284-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021284-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021284-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021284-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021284-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021284-004 | AB1 | 1 | 5bbf6a4d5a75… |
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 | N021284-001 | 6228398 | 2019-11-01 | U-472 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021284-002 | 6228398 | 2019-11-01 | U-472 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021284-003 | 6228398 | 2019-11-01 | U-472 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021284-004 | 6228398 | 2019-11-01 | U-472 | Drug product | 74a2ff9319b5… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021284-001 | 6228398 | 2019-11-01 | U-472 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021284-002 | 6228398 | 2019-11-01 | U-472 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021284-003 | 6228398 | 2019-11-01 | U-472 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021284-004 | 6228398 | 2019-11-01 | U-472 | Drug product | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021284-001 | 6228398 | 2019-11-01 | U-472 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021284-002 | 6228398 | 2019-11-01 | U-472 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021284-003 | 6228398 | 2019-11-01 | U-472 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021284-004 | 6228398 | 2019-11-01 | U-472 | Drug product | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021284-001 | 6228398 | 2019-11-01 | U-472 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021284-002 | 6228398 | 2019-11-01 | U-472 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021284-003 | 6228398 | 2019-11-01 | U-472 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021284-004 | 6228398 | 2019-11-01 | U-472 | Drug product | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Ritalin LA | METHYLPHENIDATE HYDROCHLORIDE | Novartis Pharmaceuticals Corporation | effd952d-ac94-47bb-b107-589a4934dcca | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | 0078-0371-05 00078037105 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.