Guanfacine ER
- Product NDC
- 72189-469
- Requested package NDC
- 72189-469-30
- 11-digit product format
- 721890469
- Labeler code
- 72189
- Product ID
- 72189-469_2c4def88-252f-7c8b-e063-6294a90aeb94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guanfacine ER
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA205430
- Marketing category
- ANDA
- Marketing start
- 2023-05-04
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 72189-469 | 72189-469-30 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 72189-469 | 72189-469-30 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
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 ER
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUANFACINE HYDROCHLORIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PML56A160O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 862006 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fae2df3c-2298-a3e1-e053-6294a90aeac4 | 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 |
|---|---|---|---|---|---|---|
| 72189-469-30 | Guanfacine ER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-469-30 | EA - Each | 72189-469 | abdae272-2aaf-4cee-9789-aba65e40f233 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72189-469-30 | 72189046930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-469-30) | 2023-05-04 | No | No | Current |