Guanfacine ER
- Product NDC
- 72189-693
- Requested package NDC
- 72189-693-30
- 11-digit product format
- 721890693
- Labeler code
- 72189
- Product ID
- 72189-693_5cdec1dc-833f-0806-e063-6294a90abf6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA213428
- Marketing category
- ANDA
- Marketing start
- 2026-10-02
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213428-001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | |
| A213428-002 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | |
| A213428-003 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | |
| A213428-004 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213428-001 | AB |
| A213428-002 | AB |
| A213428-003 | AB |
| A213428-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-001 | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-002 | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-003 | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-004 | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-11-25 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213428-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213428-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213428-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213428-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213428-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213428-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213428-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213428-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213428-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213428-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213428-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213428-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213428-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213428-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213428-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213428-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guanfacine ER
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUANFACINE HYDROCHLORIDE | 1 mg/1 |
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 | GUANFACINE | Slate Run Pharmaceuticals, LLC | ed65ca51-b9b0-43b9-9826-03a7be256a2a | 2025-12-01 | Warnings, Adverse reactions | 213428 ANDA213428 |
| Guanfacine | GUANFACINE | A-S Medication Solutions | 57b8ad03-a5d1-4218-8d3a-40b211da84e6 | 2024-04-15 | Warnings, Adverse reactions | 213428 ANDA213428 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72189-693-30 | 72189069330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-693-30) | 2026-10-02 | No | No | Current |