Osmolex ER
- Product NDC
- 68025-074
- Requested package NDC
- 68025-074-62
- 11-digit product format
- 680250074
- Labeler code
- 68025
- Product ID
- 68025-074_ce2e1a99-33cb-84e4-e053-2a95a90a71e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine
- Dosage form
- KIT
- Labeler
- Vertical Pharmaceuticals, LLC
- Application
- NDA209410
- Marketing category
- NDA
- Marketing start
- 2018-06-01
- Marketing end
- 2023-03-31
- Active strength
- 0
- 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 package | package | 68025-074 | 68025-074-62 | D | Discontinued by firm | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209410-001 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | |
| N209410-002 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | |
| N209410-003 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | |
| N209410-004 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209410-001 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | |
| N209410-001 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | |
| N209410-001 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | |
| N209410-001 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | |
| N209410-001 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | |
| N209410-001 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | |
| N209410-001 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-001 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-001 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | |
| N209410-001 | 11890261 | 2038-02-15 | U-2497 | 2024-03-04 | |
| N209410-002 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | |
| N209410-002 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | |
| N209410-002 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | |
| N209410-002 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | |
| N209410-002 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | |
| N209410-002 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | |
| N209410-002 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-002 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-002 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | |
| N209410-002 | 11890261 | 2038-02-15 | U-2497 | 2024-03-04 | |
| N209410-003 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | |
| N209410-003 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | |
| N209410-003 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | |
| N209410-003 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | |
| N209410-003 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | |
| N209410-003 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | |
| N209410-003 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-003 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | |
| N209410-003 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | |
| N209410-004 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | |
| N209410-004 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | |
| N209410-004 | 8252331 | 2030-03-13 | Drug product | 2020-10-29 | |
| N209410-004 | 10213393 | 2038-02-15 | U-20 | 2020-10-29 | |
| N209410-004 | 10213394 | 2038-02-15 | U-2497 | 2020-10-29 | |
| N209410-004 | 10500170 | 2038-02-15 | U-20 | 2020-10-29 | |
| N209410-004 | 10500171 | 2038-02-15 | U-2497 | 2020-10-29 | |
| N209410-004 | 10500172 | 2038-02-15 | U-2497 | 2020-10-29 | |
| N209410-004 | 10512617 | 2038-02-15 | U-2497 | 2020-10-29 |
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 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209410-001 | OSMOLEX ER | EQ 129MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209410-002 | OSMOLEX ER | EQ 193MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209410-003 | OSMOLEX ER | EQ 258MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2018-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209410-004 | OSMOLEX ER | EQ 161MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2020-04-22 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-001 | 11890261 | 2038-02-15 | U-2497 | 2024-03-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-002 | 11890261 | 2038-02-15 | U-2497 | 2024-03-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 8252331 | 2030-03-13 | Drug product | 2018-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10213393 | 2038-02-15 | U-20 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10213394 | 2038-02-15 | U-2497 | 2019-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10500170 | 2038-02-15 | U-20 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10500171 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10500172 | 2038-02-15 | U-2497 | 2019-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-003 | 10512617 | 2038-02-15 | U-2497 | 2020-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 8389578 | 2028-01-22 | U-3054 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 8389578 | 2028-01-22 | U-219 | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 8252331 | 2030-03-13 | Drug product | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10213393 | 2038-02-15 | U-20 | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10213394 | 2038-02-15 | U-2497 | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10500170 | 2038-02-15 | U-20 | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10500171 | 2038-02-15 | U-2497 | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10500172 | 2038-02-15 | U-2497 | 2020-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209410-004 | 10512617 | 2038-02-15 | U-2497 | 2020-10-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-001 | 8796337 | 2025-11-23 | U-219 | 2021-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209410-001 | 8796337 | 2025-11-23 | U-3054 | 2021-02-10 | 31067a03dcf5… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68025-074-62 | EA - Each | 68025-074 | cd3388cf-f743-4293-a361-7728520ecc7c | 1 | 2020-05-08 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68025-074-62 | 68025007462 | 1 KIT in 1 CARTON (68025-074-62) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30) | 1 kit | 2018-06-01 | 2023-03-31 | No | No | Current |