AMINOPHYLLINE
- Product NDC
- 51662-1204
- 11-digit product format
- 516621204
- Labeler code
- 51662
- Product ID
- 51662-1204_0e739cf0-6ac6-03b2-e063-6294a90a6548
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMINOPHYLLINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA087242
- Marketing category
- ANDA
- Marketing start
- 2018-09-13
- Substance
- AMINOPHYLLINE DIHYDRATE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| A087242-001 | AMINOPHYLLINE | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RLD, RS | 1983-10-26 |
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 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RLD, RS | 1983-10-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RLD, RS | 1983-10-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RLD, RS | 1983-10-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087242-001 | AMINOPHYLLINE | 25MG/ML | INJECTABLE / INJECTION | RS | 1983-10-26 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMINOPHYLLINE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMINOPHYLLINE DIHYDRATE | 25 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C229N9DX94 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1724668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1d07c79-5983-427d-b6f5-df0550dcc598 | Product name | 4 | 20250325 |
| 7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2 | Product name | 1 | 20170302 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51662-1204-1 | 2020-02-07 | C162847 | 48780-1 | 9d75b9cf-e090-f424-e053-dadaa90a57ce | AMINOPHYLLINE INJECTION, USP 250mg (25mg/mL) 10mL VIAL |
| 51662-1204-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e090-f424-e053-dadaa90a57ce | AMINOPHYLLINE INJECTION, USP 250mg (25mg/mL) 10mL VIAL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1204-1 | AMINOPHYLLINE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 8 | |
| 51662-1204-2 | AMINOPHYLLINE | 1 mL in 1 POUCH | INJECTION, SOLUTION | 1 | 8 | |
| 51662-1204-3 | AMINOPHYLLINE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1204 | AMINOPHYLLINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240109_75c2fc3e-28ac-c1b1-e053-2991aa0aee9f.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 |
|---|---|---|---|---|---|---|
| AMINOPHYLLINE | AMINOPHYLLINE | HF Acquisition Co LLC, DBA HealthFirst | 819207a2-0c37-b275-e053-2a91aa0afb36 | 2026-06-19 | Warnings, Adverse reactions | 087242 ANDA087242 |
| Aminophylline | AMINOPHYLLINE | Medical Purchasing Solutions, LLC | 52bbc6cd-4baf-7859-e063-6394a90ac87d | 2026-05-26 | Warnings, Adverse reactions | 087242 ANDA087242 |
| Aminophylline | AMINOPHYLLINE | Hospira, Inc. | 9a663ef3-881f-48bd-2689-3713b24545c2 | 2026-05-22 | Warnings, Adverse reactions | 087242 ANDA087242 |
| Aminophylline | AMINOPHYLLINE | ProPharma Distribution | 3f000254-a9f1-c8c7-e063-6394a90aa33f | 2025-12-18 | Warnings, Adverse reactions | 087242 ANDA087242 |
| Aminophylline | AMINOPHYLLINE | Henry Schein, Inc. | 9066bdd0-cb03-40ed-abfa-1b6fb1fff607 | 2025-10-27 | Warnings, Adverse reactions | 087242 ANDA087242 |
| Aminophylline | AMINOPHYLLINE | Henry Schein, Inc. | 9a9dedc4-ce04-4b22-9922-81a215ff59ed | 2025-10-27 | Warnings, Adverse reactions | 087242 ANDA087242 |
| AMINOPHYLLINE | AMINOPHYLLINE | HF Acquisition Co LLC, DBA HealthFirst | 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | 2024-01-08 | Warnings, Adverse reactions | 087242 ANDA087242 51662-1204 |
| Aminophylline | AMINOPHYLLINE | Medical Purchasing Solutions, LLC | 6bca324f-6999-4c16-e053-2a91aa0aee45 | 2023-05-30 | Warnings, Adverse reactions | 087242 ANDA087242 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1724668 | aminophylline 250 MG in 10 ML Injection | PSN | 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | 8 |
| 1724668 | 10 ML aminophylline 25 MG/ML Injection | SCD | 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | 8 |
| 1724668 | aminophylline (as aminophylline dihydrate) 250 MG per 10 ML Injection | SY | 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | 8 |
| 1724668 | aminophylline 250 MG per 10 ML Injection | SY | 75c2fc3e-28ac-c1b1-e053-2991aa0aee9f | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51662-1204-1 | 51662120401 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1204-1) | 10 ml | 2018-09-13 | 0000-00-00 | No | No | Current |
| 51662-1204-2 | 51662120402 | 1 mL in 1 POUCH | 1 ml | Historical | ||||
| 51662-1204-3 | 51662120403 | 25 POUCH in 1 CASE (51662-1204-3) / 1 mL in 1 POUCH (51662-1204-2) | 25 pouch | 2020-06-15 | 0000-00-00 | No | No | Current |