Chlorthalidone
- Product NDC
- 67877-696
- 11-digit product format
- 678770696
- Labeler code
- 67877
- Product ID
- 67877-696_c8bc4f9d-d8fe-47fa-8643-95a371c5d23b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorthalidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA213412
- Marketing category
- ANDA
- Marketing start
- 2020-02-13
- Substance
- CHLORTHALIDONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213412-001 | CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | |
| A213412-002 | CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | RS | 2020-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213412-001 | AB |
| A213412-002 | 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 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213412-001 | CHLORTHALIDONE | 25MG | TABLET / ORAL | AB | 2020-02-11 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213412-002 | CHLORTHALIDONE | 50MG | TABLET / ORAL | AB | 2020-02-11 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213412-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213412-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213412-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213412-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213412-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213412-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213412-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213412-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213412-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213412-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213412-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213412-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213412-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213412-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213412-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213412-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213412-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213412-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213412-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213412-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213412-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213412-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213412-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213412-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213412-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213412-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213412-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213412-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213412-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213412-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213412-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213412-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213412-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213412-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213412-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213412-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213412-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213412-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213412-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213412-002 | AB | 1 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlorthalidone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORTHALIDONE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Q0MQD1073Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d104583e-e983-4230-b6d1-4455ee1060a5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83fe98fe-2a14-448c-9029-41f7600d1b0a | Product name | 1 | 20260105 |
| 0450926f-f624-49c2-83be-42807e8fbcd5 | Product name | 1 | 20251113 |
| 8525e779-537f-e5cc-2515-089ecce5f50f | Product name | 9 | 20221128 |
| faf41ef3-b4b3-a29e-3b26-07c3009003bf | Product name | 5 | 20220517 |
| 3f5e2da3-8b99-f714-3261-2c998ee07b05 | Product name | 1 | 20140508 |
| 7667d8e2-e5be-36e1-4de7-231aa7fdaf5c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-696-01 | Chlorthalidone | 100 in 1 BOTTLE | TABLET | 100 | 7 | |
| 67877-696-10 | Chlorthalidone | 1000 in 1 BOTTLE | TABLET | 1000 | 7 | |
| 67877-696-33 | Chlorthalidone | 1 in 1 CARTON | TABLET | 1 | 7 | |
| 67877-696-33 | Chlorthalidone | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 67877-696-38 | Chlorthalidone | 10 in 1 CARTON | TABLET | 10 | 7 | |
| 67877-696-38 | Chlorthalidone | 10 in 1 BLISTER PACK | TABLET | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-696-01 | EA - Each | 67877-696 | d0007fdf-0439-4dc5-ae18-1c50aac3b151 | 1 | 2020-04-20 |
| 67877-696-10 | EA - Each | 67877-696 | 4d3015c8-491c-46f8-bc2d-d32ef53f3ec8 | 1 | 2020-04-20 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chlorthalidone | CHLORTHALIDONE | REMEDYREPACK INC. | 7d8e26e6-7314-4799-b137-934926d343b0 | 2026-06-01 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | A-S Medication Solutions | 583992c2-b789-4267-9a8f-c1ee5db3f29f | 2026-02-19 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | A-S Medication Solutions | 7d09c992-22f7-41e1-a836-380712f242c0 | 2025-12-30 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Preferred Pharmaceuticals Inc. | d61367af-530b-4e5e-8e71-11c93f75ecf1 | 2025-11-17 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Direct_Rx | 401ae38b-2eb8-c9fc-e063-6294a90af220 | 2025-10-01 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Bryant Ranch Prepack | 165e5993-eb9d-4664-97dc-574ae5e0e946 | 2025-09-29 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Ascend Laboratories, LLC | d104583e-e983-4230-b6d1-4455ee1060a5 | 2025-04-23 | Warnings, Adverse reactions | 213412 ANDA213412 67877-696 |
| Chlorthalidone | CHLORTHALIDONE | Coupler LLC | 2ccba8ab-4c34-af52-e063-6394a90a78d3 | 2025-01-28 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Bryant Ranch Prepack | e727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1 | 2024-01-11 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Bryant Ranch Prepack | a1ab541b-7515-4888-b3e0-aca52875562d | 2024-01-11 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | Bryant Ranch Prepack | 98f4a14c-2863-4068-bd35-aaedcc872680 | 2023-11-27 | Warnings, Adverse reactions | 213412 ANDA213412 |
| Chlorthalidone | CHLORTHALIDONE | A-S Medication Solutions | c5796482-ad1f-437a-ae80-c288880f4100 | 2023-10-16 | Warnings, Adverse reactions | 213412 ANDA213412 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-696-01 | 67877069601 | 100 TABLET in 1 BOTTLE (67877-696-01) | 100 tablet | 2020-02-13 | 0000-00-00 | No | No | Current |
| 67877-696-10 | 67877069610 | 1000 TABLET in 1 BOTTLE (67877-696-10) | 1000 tablet | 2020-02-13 | 0000-00-00 | No | No | Current |
| 67877-696-33 | 67877069633 | 1 BLISTER PACK in 1 CARTON (67877-696-33) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-02-13 | 0000-00-00 | No | No | Current |
| 67877-696-38 | 67877069638 | 10 BLISTER PACK in 1 CARTON (67877-696-38) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2020-02-13 | 0000-00-00 | No | No | Current |