Dexmethylphenidate Hydrochloride
- Product NDC
- 63629-2177
- 11-digit product format
- 636292177
- Labeler code
- 63629
- Product ID
- 63629-2177_c44324aa-291f-4415-986e-7db006f7fce9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202842
- Marketing category
- ANDA
- Marketing start
- 2017-01-05
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 63629-2177 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63629-2177 | 63629-2177-1 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | |
| A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202842-001 | AB |
| A202842-002 | AB |
| A202842-003 | AB |
| A202842-004 | AB |
| A202842-005 | AB |
| A202842-006 | AB |
| A202842-007 | AB |
| A202842-008 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-30 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202842-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202842-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202842-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202842-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202842-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202842-008 | AB | 1 | fd3edfee7708… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2177-1 | EA - Each | 63629-2177 | 46bf5a6f-44b4-4494-882c-ff90461d7f11 | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2177 | DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 104 | Legacy NDC | 20240816_385dccf3-7840-4e15-8040-b2cae9327a42.zip |
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 |
|---|---|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | d9c450fa-c8c5-4ff0-a263-4a9eee6f5437 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b82e8d08-cc4a-40a6-85a5-07717f3cb38b | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b7410d65-9c7f-4ffd-b957-969e2725f38f | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 9700cc3d-52e9-40e4-8595-f1c56279a2e0 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 6593b3ae-efcc-49ff-ba51-3fb5558605e5 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 06bcef7a-b321-4dd8-9bf6-5d8f8940f04a | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | a03d8819-a315-4337-ac50-530af98082b0 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 424da264-7448-4364-939f-d3ebbee1a6d7 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | d3318fec-a1bc-4e3c-86a9-3f00ec296869 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | c423a632-e8e0-44a7-a8a8-f66cec81aa64 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Par Health USA, LLC | e304388e-86a6-4335-abae-0ce79c7c99c6 | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | 202842 ANDA202842 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-2177-1 | 63629217701 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2177-1) | 2021-12-22 | 0000-00-00 | No | No | Current |