Guanfacine extended-release
- Product NDC
- 60505-3927
- 11-digit product format
- 605053927
- Labeler code
- 60505
- Product ID
- 60505-3927_be71bf36-161d-d944-6044-1bbe8d133d28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA205430
- Marketing category
- ANDA
- Marketing start
- 2018-10-03
- Substance
- GUANFACINE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 60505-3927 | 60505-3927-3 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 60505-3927 | 60505-3927-8 | D | Discontinued by firm | 2026-08-11 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-3927-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 60505-3927-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-3927-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 60505-3927-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-3927-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 60505-3927-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-3927-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 60505-3927-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-3927-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 60505-3927-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-3927-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 60505-3927-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-3927-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 60505-3927-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-3927-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 60505-3927-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-3927-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 60505-3927-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-3927-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 60505-3927-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-3927-8 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 60505-3927-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-3927-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 60505-3927-8 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205430-001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | |
| A205430-002 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | |
| A205430-003 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | |
| A205430-004 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205430-001 | AB |
| A205430-002 | AB |
| A205430-003 | AB |
| A205430-004 | 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 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-07-25 | 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 | A205430-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205430-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205430-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205430-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205430-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205430-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205430-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205430-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205430-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205430-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205430-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine extended-release
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUANFACINE HYDROCHLORIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PML56A160O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c492e87-3406-ddb8-aaf2-e609c2ded503 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 44b80df7-57c9-56d4-c87a-f0d57d327460 | Product name | 9 | 20260127 |
| 4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0 | Product name | 3 | 20230308 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-3927-1 | Guanfacine extended-release | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 12 | |
| 60505-3927-3 | Guanfacine extended-release | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 12 | |
| 60505-3927-8 | Guanfacine extended-release | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-3927-1 | EA - Each | 60505-3927 | 91c918cd-d0ba-4a9c-a4c0-271843f31042 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-3927 | GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [APOTEX CORP.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240927_1c492e87-3406-ddb8-aaf2-e609c2ded503.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 |
|---|---|---|---|---|---|---|
| Guanfacine extended-release | GUANFACINE | Apotex Corp. | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 2026-05-06 | Warnings, Adverse reactions | 205430 ANDA205430 60505-3927 |
| Guanfacine extended-release | GUANFACINE | Bryant Ranch Prepack | 1c5d9514-641a-4c72-a79a-96a0fe5d6fbd | 2026-02-13 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine extended-release | GUANFACINE | Bryant Ranch Prepack | 07cda4a1-0eb5-491e-8d16-4e6a6feb93ac | 2026-02-10 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine extended-release | GUANFACINE | Bryant Ranch Prepack | 187bd24b-d69b-4cdf-be4a-c89e9b131b81 | 2025-11-05 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine extended-release | GUANFACINE | Bryant Ranch Prepack | 178b649f-8c0f-4fea-a168-3ce4ff52129d | 2025-10-30 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine extended-release | GUANFACINE | REMEDYREPACK INC. | 8348e63a-5cbc-489e-b7bf-046c65ba2e8e | 2025-09-30 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine ER | GUANFACINE ER | Direct_Rx | fae2df3c-2298-a3e1-e053-6294a90aeac4 | 2025-01-22 | Warnings, Adverse reactions | 205430 ANDA205430 |
| Guanfacine extended-release | GUANFACINE | A-S Medication Solutions | 07797c4a-a799-436b-a77c-a2861a811a99 | 2023-05-23 | Warnings, Adverse reactions | 205430 ANDA205430 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 862006 | guanFACINE 1 MG 24HR Extended Release Oral Tablet | PSN | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862013 | guanFACINE 2 MG 24HR Extended Release Oral Tablet | PSN | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862019 | guanFACINE 3 MG 24HR Extended Release Oral Tablet | PSN | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862025 | guanFACINE 4 MG 24HR Extended Release Oral Tablet | PSN | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862006 | 24 HR guanfacine 1 MG Extended Release Oral Tablet | SCD | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862013 | 24 HR guanfacine 2 MG Extended Release Oral Tablet | SCD | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862019 | 24 HR guanfacine 3 MG Extended Release Oral Tablet | SCD | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862025 | 24 HR guanfacine 4 MG Extended Release Oral Tablet | SCD | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862013 | guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862013 | guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862019 | guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862019 | guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862025 | guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862025 | guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet | SY | 1c492e87-3406-ddb8-aaf2-e609c2ded503 | 12 |
| 862006 | guanFACINE 1 MG 24HR Extended Release Oral Tablet | PSN | fae2df3c-2298-a3e1-e053-6294a90aeac4 | 2 |
| 862006 | 24 HR guanfacine 1 MG Extended Release Oral Tablet | SCD | fae2df3c-2298-a3e1-e053-6294a90aeac4 | 2 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet | SY | fae2df3c-2298-a3e1-e053-6294a90aeac4 | 2 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet | SY | fae2df3c-2298-a3e1-e053-6294a90aeac4 | 2 |
| 862006 | guanFACINE 1 MG 24HR Extended Release Oral Tablet | PSN | 1c5d9514-641a-4c72-a79a-96a0fe5d6fbd | 1 |
| 862006 | 24 HR guanfacine 1 MG Extended Release Oral Tablet | SCD | 1c5d9514-641a-4c72-a79a-96a0fe5d6fbd | 1 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet | SY | 1c5d9514-641a-4c72-a79a-96a0fe5d6fbd | 1 |
| 862006 | guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet | SY | 1c5d9514-641a-4c72-a79a-96a0fe5d6fbd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-3927-1 | 60505392701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-1) | 2018-10-03 | 0000-00-00 | No | No | Current |
| 60505-3927-3 | 60505392703 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-3) | 2018-10-03 | 0000-00-00 | No | No | Current |
| 60505-3927-8 | 60505392708 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-8) | 2018-10-03 | 0000-00-00 | No | No | Current |