What is NDC 0480-3312?

0480-3312 is the product NDC for Tolvaptan kit, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tolvaptan?

41 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tolvaptan NDC 0480-3312 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3312Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0480-3312-66	0048033126600480331266	4 BLISTER PACK in 1 CARTON (0480-3312-66) / 1 KIT in 1 BLISTER PACK (0480-3312-14) * 7 TABLET in 1 BLISTER PACK (0480-4082-11) * 7 TABLET in 1 BLISTER PACK (0480-3265-11)Marketed from Aug 27, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tolvaptan
Generic name (nonproprietary): tolvaptan
Dosage form: Kit
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216933
Marketing start: Aug 27, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 0480-3312_55f269ec-f4f3-48c0-a7ea-b5d8a97344d9SPL ID 55f269ec-f4f3-48c0-a7ea-b5d8a97344d9SPL set ID 808a9a1f-2f58-4677-9127-e749ad007094RxCUI 2044359, 2044363, 2044367, 2044966, 2044968, 2044970, 2274813, 2274815, 2719335, 2719337

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400480331266 followed by a unit qualifier and the quantity

Package 00480-3312-66. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-3312

What is NDC 0480-3312?: 0480-3312 is the product NDC for Tolvaptan kit, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tolvaptan.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tolvaptan?: 41 other product NDCs are listed under this name. See all Tolvaptan NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tolvaptan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tolvaptan	Tolvaptan 15 mg/1	TabletOral	Ascend Laboratories, LLC	67877-915	67877-0915-30
Tolvaptan	Tolvaptan 30 mg/1	TabletOral	Ascend Laboratories, LLC	67877-916	67877-0916-30
Tolvaptan	Tolvaptan 45 mg/1	TabletOral	Ascend Laboratories, LLC	67877-917	67877-0917-30
Tolvaptan	Tolvaptan 60 mg/1	TabletOral	Ascend Laboratories, LLC	67877-918	67877-0918-30
Tolvaptan	Tolvaptan 90 mg/1	TabletOral	Ascend Laboratories, LLC	67877-919	67877-0919-30
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-920	67877-0920-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-921	67877-0921-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-922	67877-0922-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-923	67877-0923-54
Tolvaptan	—	Kit	Ascend Laboratories, LLC	67877-924	67877-0924-54

All 42 Tolvaptan NDCs

Other NDCs under ANDA 216933

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216933
Product	Strength	Form · route	Labeler	Product NDC
Tolvaptan	—	Kit	Teva Pharmaceuticals, Inc.	0480-3311
Tolvaptan	—	Kit	Teva Pharmaceuticals, Inc.	0480-3313
Tolvaptan	—	Kit	Teva Pharmaceuticals, Inc.	0480-3314
Tolvaptan	—	Kit	Teva Pharmaceuticals, Inc.	0480-3414