GLYCOPYRROLATE
- Product NDC
- 63629-7207
- 11-digit product format
- 636297207
- Labeler code
- 63629
- Product ID
- 63629-7207_231a1231-822a-443b-a8f1-fba28fe3d64c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYCOPYRROLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202675
- Marketing category
- ANDA
- Marketing start
- 2013-04-15
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- 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 |
|---|---|---|---|---|---|---|---|
| A202675-001 | GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | |
| A202675-002 | GLYCOPYRROLATE | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202675-001 | AA |
| A202675-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC | 2025-01 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC | 2025-01 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202675-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2013-04-15 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202675-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2018-10-30 | 3f01610625f2… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC | 2025-01 | A202675-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC | 2025-01 | A202675-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202675-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202675-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202675-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202675-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202675-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202675-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202675-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202675-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202675-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202675-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202675-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202675-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202675-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202675-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202675-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202675-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202675-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202675-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202675-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202675-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202675-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202675-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202675-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202675-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202675-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202675-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202675-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202675-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202675-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202675-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202675-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202675-002 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202675-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202675-002 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202675-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202675-002 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202675-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202675-002 | AA | 1 | 3f01610625f2… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | GLYCOPYRROLATE | REMEDYREPACK INC. | 220cd5f5-3d71-4fdb-9943-7468799c179f | 2026-06-02 | Warnings, Adverse reactions | 202675 ANDA202675 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | 098c7654-a352-47ee-bf23-6a81f8601266 | 2026-05-05 | Warnings, Adverse reactions | 202675 ANDA202675 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | 21c7d201-c0b8-4f16-be4a-681d0b22791e | 2026-04-03 | Warnings, Adverse reactions | 202675 ANDA202675 63629-7207 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | NCS HealthCare of KY, LLC dba Vangard Labs | 5ed930b7-a36e-4bf8-b1d1-dad238d3dd18 | 2026-02-25 | Warnings, Adverse reactions | 202675 ANDA202675 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Aurolife Pharma LLC | 677f8495-a870-45b6-bb65-75b449f040ce | 2025-12-11 | Warnings, Adverse reactions | 202675 ANDA202675 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | American Health Packaging | 6404fc8e-d109-4950-9dca-c8a85ad90cf3 | 2025-05-18 | Warnings, Adverse reactions | 202675 ANDA202675 |
| Glycopyrrolate | GLYCOPYRROLATE | AvPAK | bd497783-e2d1-130c-e053-2995a90a7fb9 | 2025-03-04 | Warnings, Adverse reactions | 202675 ANDA202675 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GLYCOPYRROLATE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYCOPYRROLATE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V92SO9WP2I | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197738 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 21c7d201-c0b8-4f16-be4a-681d0b22791e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 138c3de2-4b03-4255-92b5-f022482d81bc | Product name | 4 | 20260113 |
| 4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e | Product name | 5 | 20250304 |
| f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b | Product name | 1 | 20231002 |
| 76dcac30-469f-4f92-9c55-70950d209446 | Product name | 1 | 20230809 |
| 132196a6-5117-4b6e-a9dd-27f2793580c6 | Product name | 1 | 20230112 |
| ac1f888b-a1db-4d2e-abbc-973f21c2ce1b | Product name | 1 | 20220720 |
| d84dd569-7bf0-1410-25eb-017ef37dd406 | Product name | 9 | 20210902 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 58b12de9-b891-41c7-9be6-ff47de5ec28b | Product name | 1 | 20180828 |
| 9aff7b10-8e47-4b10-9a92-803440a37ce2 | Product name | 1 | 20180206 |
| ce066c73-ca6f-49fc-83d4-d3cf6728e8a1 | Product name | 1 | 20160616 |
| fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a | Product name | 1 | 20151113 |
| ab7ba50c-5a47-47e6-8dd6-fa32a52559f6 | Product name | 1 | 20151109 |
| 29ae08d1-069f-9822-4820-152d5dc67797 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-7207-1 | GLYCOPYRROLATE | 30 in 1 BOTTLE | TABLET | 30 | 12 | |
| 63629-7207-2 | GLYCOPYRROLATE | 270 in 1 BOTTLE | TABLET | 270 | 12 | |
| 63629-7207-3 | GLYCOPYRROLATE | 28 in 1 BOTTLE | TABLET | 28 | 12 | |
| 63629-7207-4 | GLYCOPYRROLATE | 90 in 1 BOTTLE | TABLET | 90 | 12 | |
| 63629-7207-5 | GLYCOPYRROLATE | 100 in 1 BOTTLE | TABLET | 100 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-7207 | GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK] | 11 | Current NDC, Legacy NDC, 5 package rows | 20240912_21c7d201-c0b8-4f16-be4a-681d0b22791e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197738 | glycopyrrolate 1 MG Oral Tablet | PSN | 21c7d201-c0b8-4f16-be4a-681d0b22791e | 12 |
| 197738 | glycopyrrolate 1 MG Oral Tablet | SCD | 21c7d201-c0b8-4f16-be4a-681d0b22791e | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-7207-1 | 63629720701 | 30 TABLET in 1 BOTTLE (63629-7207-1) | 30 tablet | 2021-02-18 | 0000-00-00 | No | No | Current |
| 63629-7207-2 | 63629720702 | 270 TABLET in 1 BOTTLE (63629-7207-2) | 270 tablet | 2017-03-02 | 0000-00-00 | No | No | Current |
| 63629-7207-3 | 63629720703 | 28 TABLET in 1 BOTTLE (63629-7207-3) | 28 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 63629-7207-4 | 63629720704 | 90 TABLET in 1 BOTTLE (63629-7207-4) | 90 tablet | 2017-12-15 | 0000-00-00 | No | No | Current |
| 63629-7207-5 | 63629720705 | 100 TABLET in 1 BOTTLE (63629-7207-5) | 100 tablet | 2024-09-05 | No | No | Current |