ASPRUZYO SPRINKLE
- Product NDC
- 47335-624
- 11-digit product format
- 473350624
- Labeler code
- 47335
- Product ID
- 47335-624_110acc77-c51e-465f-8d01-2c01f69af87b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- Application
- NDA216018
- Marketing category
- NDA
- Marketing start
- 2022-02-28
- Marketing end
- 0000-00-00
- Substance
- RANOLAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 47335-624 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 47335-624 | 47335-624-11 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 47335-624 | 47335-624-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 47335-624 | 47335-624-60 | D | Discontinued by firm | 2026-08-17 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 47335-624-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 47335-624-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 47335-624-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 47335-624-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 47335-624-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 47335-624-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 47335-624-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 47335-624-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 47335-624-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 47335-624-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 47335-624-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 47335-624-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 47335-624-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 47335-624-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 47335-624-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 47335-624-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 47335-624-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 47335-624-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 47335-624-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 47335-624-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 47335-624-60 | 302b2466d912… | e7b80fea0513… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216018-001 | ASPRUZYO SPRINKLE | RANOLAZINE | 500MG | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | |
| N216018-002 | ASPRUZYO SPRINKLE | RANOLAZINE | 1GM | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | |
| N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | |
| N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | |
| N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 |
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 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 4b0b4de00fa7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 1c564ffb4f44… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4367aed1-e488-b72c-d0ec-178a4e054129 | Product name | 9 | 20250624 |
| ddc83a74-720a-4975-8550-c4bd979c9094 | Product name | 1 | 20221212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47335-624-11 | ASPRUZYO SPRINKLE | 1 in 1 PACKET | GRANULE | 1 | 3 | |
| 47335-624-30 | ASPRUZYO SPRINKLE | 30 in 1 CARTON | GRANULE | 30 | 3 | |
| 47335-624-60 | ASPRUZYO SPRINKLE | 60 in 1 CARTON | GRANULE | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47335-624-11 | EA - Each | 47335-624 | 64c00877-ceaf-44b5-8cd1-4da023827e63 | 1 | 2022-08-04 |
| 47335-624-60 | EA - Each | 47335-624 | d2534668-2131-42ef-8610-300eb93c1318 | 1 | 2022-07-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ASPRUZYO SPRINKLE | RANOLAZINE | SUN PHARMACEUTICAL INDUSTRIES, INC. | dd9f81e4-50da-4551-aed5-559d304df42e | 2025-01-29 | Warnings, Adverse reactions | 216018 NDA216018 47335-624 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2594759 | ASPRUZYO Sprinkle 1000 MG Oral Granules | PSN | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594762 | ASPRUZYO Sprinkle 500 MG Oral Granules | PSN | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594753 | ranolazine 1000 MG Oral Granules | PSN | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594760 | ranolazine 500 MG Oral Granules | PSN | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594759 | ranolazine 1000 MG Oral Granules [Aspruzyo] | SBD | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594762 | ranolazine 500 MG Oral Granules [Aspruzyo] | SBD | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594753 | ranolazine 1000 MG Oral Granules | SCD | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594760 | ranolazine 500 MG Oral Granules | SCD | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594759 | Aspruzyo 1000 MG Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594762 | Aspruzyo 500 MG Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594759 | Aspruzyo Sprinkle 1 GM Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594759 | Aspruzyo Sprinkle 1000 MG Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594762 | Aspruzyo Sprinkle 500 MG Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
| 2594753 | ranolazine 1 GM Oral Granules | SY | dd9f81e4-50da-4551-aed5-559d304df42e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47335-624-11 | 47335062411 | 1 GRANULE in 1 PACKET (47335-624-11) | 1 granule | 2022-02-28 | 0000-00-00 | No | No | Current |
| 47335-624-30 | 47335062430 | 30 GRANULE in 1 CARTON (47335-624-30) | 30 granule | 2022-02-28 | 0000-00-00 | No | No | Current |
| 47335-624-60 | 47335062460 | 60 GRANULE in 1 CARTON (47335-624-60) | 60 granule | 2022-02-28 | 0000-00-00 | No | No | Current |