Atropine Sulfate
- Product NDC
- 71872-7316
- Requested package NDC
- 71872-7316-1
- 11-digit product format
- 718727316
- Labeler code
- 71872
- Product ID
- 71872-7316_0aab02be-9f0a-1b7f-e063-6294a90a7011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION
- Route
- ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Medical Purchasing Solutions, LLC
- Application
- ANDA213561
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- Substance
- ATROPINE SULFATE
- Active strength
- .4 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- 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 |
|---|---|---|---|---|---|---|---|
| A213561-001 | ATROPINE SULFATE | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213561-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213561-001 | ATROPINE SULFATE | 8MG/20ML (0.4MG/ML) | SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | AP | 2021-12-01 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213561-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213561-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213561-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213561-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213561-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213561-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213561-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213561-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213561-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213561-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213561-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213561-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213561-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213561-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213561-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213561-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213561-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213561-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213561-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213561-001 | AP | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213561-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213561-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213561-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213561-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213561-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213561-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213561-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213561-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A213561-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213561-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213561-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A213561-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213561-001 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213561-001 | AP | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atropine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATROPINE SULFATE | .4 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 03J5ZE7KA5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1190776 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0aab13de-04bf-2a14-e063-6294a90aae11 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71872-7316-1 | Atropine Sulfate | 20 mL in 1 VIAL | INJECTION | 20 | 1 | |
| 71872-7316-1 | Atropine Sulfate | 1 in 1 BAG | INJECTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71872-7316 | ATROPINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 1 | Current NDC, 2 package rows | 20231122_0aab13de-04bf-2a14-e063-6294a90aae11.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 |
|---|---|---|---|---|---|---|
| Atropine Sulfate | ATROPINE SULFATE | REMEDYREPACK INC. | 8663ff94-8bea-4061-9fd5-3ab2e85e862e | 2025-10-02 | Warnings, Adverse reactions | 213561 ANDA213561 |
| ATROPINE SULFATE | ATROPINE SULFATE | HF Acquisition Co LLC, DBA HealthFirst | e9fd624a-9abd-dfea-e053-2a95a90a8e9d | 2024-01-28 | Warnings, Adverse reactions | 213561 ANDA213561 |
| Atropine Sulfate | ATROPINE SULFATE | Medical Purchasing Solutions, LLC | 0aab13de-04bf-2a14-e063-6294a90aae11 | 2023-11-15 | Warnings, Adverse reactions | 213561 ANDA213561 71872-7316-1 71872-7316 71872731601 |
| Atropine Sulfate | ATROPINE SULFATE | Hikma Pharmaceuticals USA Inc. | 4c15d3cc-7888-4c82-b3f8-a5d93c5523df | 2023-01-26 | Warnings, Adverse reactions | 213561 ANDA213561 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190776 | atropine sulfate 0.4 MG/ML Injectable Solution | PSN | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
| 1190776 | atropine sulfate 0.4 MG/ML Injectable Solution | SCD | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
| 1190776 | atropine sulfate 1 MG per 2.5 ML Injectable Solution | SY | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
| 1190776 | atropine sulfate 1.2 MG per 3 ML Injectable Solution | SY | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
| 1190776 | atropine sulfate 2 MG per 5 ML Injectable Solution | SY | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
| 1190776 | atropine sulfate 8 MG per 20 ML Injectable Solution | SY | 0aab13de-04bf-2a14-e063-6294a90aae11 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71872-7316-1 | 71872731601 | 1 VIAL in 1 BAG (71872-7316-1) / 20 mL in 1 VIAL | 1 vial | 2023-10-19 | No | No | Current |