methylphenidate hydrochloride
- Product NDC
- 0591-2716
- 11-digit product format
- 005912716
- Labeler code
- 0591
- Product ID
- 0591-2716_6b2dcacd-6280-421e-8ac2-ac00db79a5d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021121
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2011-04-01
- Marketing end
- 2021-09-30
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 27 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0591-2716 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 0591-2716 | 0591-2716-01 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 0591-2716 | 0591-2716-30 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0591-2716-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0591-2716-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0591-2716-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0591-2716-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0591-2716-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0591-2716-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0591-2716-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0591-2716-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0591-2716-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0591-2716-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0591-2716-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0591-2716-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0591-2716-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0591-2716-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0591-2716-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0591-2716-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0591-2716-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0591-2716-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0591-2716-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0591-2716-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0591-2716-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0591-2716-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0591-2716-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0591-2716-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021121-001 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 |
| N021121-002 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 |
| N021121-003 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 |
| N021121-004 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021121-001 | AB |
| N021121-002 | AB |
| N021121-003 | AB |
| N021121-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-001 | CONCERTA | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-002 | CONCERTA | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-003 | CONCERTA | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-004 | CONCERTA | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-04-01 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021121-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021121-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021121-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021121-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021121-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021121-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021121-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021121-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021121-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021121-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021121-004 | AB | 1 | d06236e962d9… |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-2716-01 | EA - Each | 0591-2716 | 3e43e2da-ad6b-4af4-a211-0b78a2db0545 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | Janssen Pharmaceuticals, Inc. | 1a88218c-5b18-4220-8f56-526de1a276cd | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | 021121 NDA021121 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091155 | methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet | PSN | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |
| 1091170 | methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet | PSN | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |
| 1091155 | 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet | SCD | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |
| 1091170 | 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet | SCD | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |
| 1091155 | methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral Tablet | SY | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |
| 1091170 | methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral Tablet | SY | 2bfb390f-ba99-4d21-8a9e-50fa8ec217c0 | 1 |